sohealthy Project

The Strategic Research Agenda disseminates the key research priorities of the footcare industry for the
period 2015-2020. The objective of this agenda is to develop a global strategy that transforms the footcare
industry effectively and efficiently towards a patient/user-oriented approach by means of a coherent R&D
strategy on a global scale.
The document carries the names of the authors and should be cited accordingly. The findings,
interpretations, and conclusions expressed in this document are entirely those of the authors and its
contributors. They do not necessarily represent the view of the European Commission or the countries they
represent. This document, as well as other project documents are available online at the private are of the
Sohealthy project Website: http://www.sohealthyproject.eu

2A A Strategic Research Agenda for the Footcare sector (2015-2020)
Authors
Project Coordinator: Lead authors:
Project partners:
Enrique Montiel
Victoria Barrantes Romero
Editing: Irene Bellod
Chris Nester
Carina Price
Mauro Tescaro
Rosanna Fornasiero
Alice Marcato
Naïma Sanaa
Nadia Somai
Amira Barkaoui
Zmirili My Youssef
Aissam Malouk
Sara Gueddari

Table of Contents
FOREWORD ..................................................................................................................................................5
Acronyms and abbreviations.........................................................................................................................6
Executive summary.......................................................................................................................................7
1. What is the Scope of the Problem?.....................................................................................................11
1.1 Diabetes......................................................................................................................................11
1.2 Obesity and overweight...............................................................................................................13
1.3 Elderly.........................................................................................................................................14
1.4 Diabetes, obesity and ageing in the MENA region........................................................................15
2 Country Overviews.............................................................................................................................18
2.1 Italy.............................................................................................................................................18
2.1.1 Diabetes ................................................................................................................................18
2.1.2 Overweight and obese ...........................................................................................................20
2.1.3 Elderly ...................................................................................................................................20
2.1.4 The orthopaedic footwear sector in Italy................................................................................23
2.2 Morocco......................................................................................................................................28
2.2.1 Diabetes ................................................................................................................................28
2.2.3 Elderly ...................................................................................................................................30
2.2.4 The orthopaedic footwear sector in Morocco ........................................................................30
2.3 Spain...........................................................................................................................................32
2.3.1 Diabetes ................................................................................................................................32
2.3.2 Overweight and obesity .........................................................................................................35
2.3.3 Elderly ...................................................................................................................................37
2.3.4 The orthopaedic footwear sector in Spain..............................................................................37
2.4 Tunisia.........................................................................................................................................40
2.4.1 Diabetes ................................................................................................................................40
2.4.3 Elderly ...................................................................................................................................42
2.4.4 The orthopaedic footwear sector in Tunisia ...........................................................................43
2.5 United Kingdom...........................................................................................................................45
2.5.1 Diabetes ................................................................................................................................45
2.5.3 Elderly ...................................................................................................................................46
2.5.4 The orthopaedic footwear sector in Uk..................................................................................46

3 Methodology......................................................................................................................................48
3.1 State of the Art Document...........................................................................................................49
3.2 Partner Expertise Document........................................................................................................49
3.3 Other Tasks .................................................................................................................................50
3.4 SOA Validation from Expert Community ......................................................................................50
3.5 Working Groups ..........................................................................................................................50
4 Impact through a user oriented research............................................................................................56
5 Research and innovation strategies ....................................................................................................58
5.1 Towards more efficient provision ................................................................................................58
5.1.1 Challenges .............................................................................................................................59
5.1.2 Research priorities.................................................................................................................63
5.2 Towards reduced foot infection...................................................................................................69
5.2.1 Challenges .............................................................................................................................70
5.2.2 Research priorities.....................................................................................................................72
5.3 Towards material innovations......................................................................................................76
5.3.1 Challenges .............................................................................................................................77
5.4 Up-skill providers.........................................................................................................................86
5.4.1 Challenges .............................................................................................................................86
5.5 End-user driven...........................................................................................................................94
5.5.1 Challenges .............................................................................................................................94
5.6 Cross-cutting issues...................................................................................................................101
6 Recommendations & Needed Initiatives...........................................................................................106
6.1 Italy...........................................................................................................................................106
6.2 Morocco....................................................................................................................................107
6.3 Spain.........................................................................................................................................108
6.4 Tunisia.......................................................................................................................................109
6.5 United Kingdom.........................................................................................................................110
7 Conclusion........................................................................................................................................112
8 Acknowledgements..........................................................................................................................113

FOREWORD
From the very beginning, the SoHealthy project "Mediterranean Research Network on Footcare Sector" has
promoted and encouraged active collaboration between countries with different cultures, languages and
beliefs, using science and technology as a means for cohesion and link. This has helped us strengthen our
relationships, promote understanding and respect towards cultural diversity and set the basis for future
collaboration.
This close collaboration became a reality through the development of this Strategic Research Agenda,
which relied on the participation of more than 40 experts from 9 EU and Euro-Med countries in an
unprecedented cooperation in the field of footcare. For the first time ever, experts from different sectors
(clinicians, producers, providers, training institutions, public authorities) discussed what the research
priorities should be for the footcare sector in the coming years, taking into account the health
professionals' opinions and focusing on the needs of diabetics, adults who are obese and the elderly. This
will help the industry face the main challenges of the sector and conceive new products that are really
intended to specifically meet the needs of these groups.
We can therefore ratify that the development of this Agenda favoured not only the cooperation between
professionals from different segments of the value chain, including footcare professionals, researchers,
industrialists and academic experts, but also the cooperation between different countries in highly
awareness-raising issues with a global incidence. According to the European Commission, as stated in the
'Report on the Implementation of the Strategy for International Cooperation in Research and Innovation',
global challenges call for global responses and drivers for international cooperation.
We hope this Agenda will help the footcare industry focus its efforts on priority research lines, thus acting
as a guiding light for the sector towards a more efficient and user-oriented future. Likewise, we hope that
footcare-related health professionals will find this Agenda a useful reference document to gain knowledge
relating to this industry and its’ varied stakeholders.
We would like to highlight that the successful implementation of this strategic research agenda requires
active participation and strong support of the European Commission and national governments. We have
set the basis for a new research framework on the footcare sector within the next five years, but only with
their support will the transformation of the sector be possible, with the EU Footcare industry becoming a
global leader.
We would like to thank all those individuals and organisations who contributed to the preparation of this
Agenda for their eagerness, effort and hard work, and making it possible for this agenda to be now a reality.
And last but not least, our special thanks to the European Commission for their financial support and for
believing in our project.
The SoHealthy team.
“Working together, challenges are an opportunity to grow”

Acronyms and abbreviations
Acronym/Abbreviation Description
EC European Commission
SRA Strategic research agenda
WGs Working Groups
SoA State of the Art
PC Project Coordinator
TL Task leader
NHS National Health Service
DM Diabetes Mellitus
T2DM Type 2 Diabetes Mellitus
T1DM Type 1 Diabetes Mellitus
INE Spanish National Statistics Institute
DFU Diabetic Foot Unit
DFIs Diabetic Foot Infections
WHO World Health Organization
IDF International Diabetes Federation
BMI Body Mass Index
SGDF Spanish Group on Diabetic Foot
GDP Gross Domestic Product
MENA Middle East and North Africa
ISTAT The Italian National Institute for Statistics
NAOS Strategy for Nutrition, Physical Activity, and Obesity Prevention
INSP National Public Health Institute of Tunisia
INNTA Tunisian National Institute of Nutrition and Food Technology
INS Institut national de la statistique (Tunisie)
HCP High Commission for Planning
AMSP Scientific Moroccan Association of Podiatrists
INNTA National Institute of Nutrition and Food Technology
NHS National Health System in UK
CNAM Tunisie Nouveau régime d'assurance maladie
3D Three Dimensional
CAD Computer Aided Design
CAM Computer Aided Manufacturing
APPS Applications
AM Additive Manufacturing

Executive summary
This document aims to describe vision and strategies for the future of the footcare sector in Europe and in
North African countries with a particular focus on challenges related to the foot health of adults who are
obese, diabetic and elderly, healthy products and training actors of the footcare value chain. The document
is the result of the roadmapping activities undertaken within the Sohealthy project by the consortium with
the support of experts from many different countries and disciplines.
The Strategic Research Agenda addresses three of the biggest socio-economic challenges in our era:
diabetes, obesity and the ageing population. The specific target is the impact on foot health that these
three conditions have and the important economic, social and human implications.
The main facts and figures related to these challenges are:
 The prevalence of diabetes is increasing in all countries.
 In 2011 there were 366 million people with diabetes and this is expected to rise to 552 million by
2030 (9.9% of the adult population worldwide).
 Low - and middle - income countries will experience the greatest increase over the next years.
 Middle East and North Africa region (MENA) has developed high proportions of diabetes where one
in ten adults in the region have the disease.
 The diabetic foot syndrome is a chronic complication of DM, the consequences of which
considerably reduce patients’ quality of life.
 There is a strong link between diabetes and obesity.
 Based on the latest estimates in European Union countries, overweight affects 30-70% and obesity
affects 10-30% of adults.
 Over 60% of children who are overweight before puberty will be overweight in early adulthood.
 By 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in
numbers of over-80s.
The analysis of the situation in the project participant countries (Italy, Morocco, Spain, Tunisia and United
Kingdom) reveals that:
Italy
In 2013 in Italy, there was a prevalence of diabetic people equal to 5.4%, and this pathology is among
the main priorities of the current National Health Plan.
The proportion of overweight in Italy is the 35.9% of the adult population while obese is 10.6%,
corresponding to approximately 4 million of people. The highest proportion is in the South of Italy.

In Italy, adults over 65 years of age are the prime users of healthcare resources, which has led the
NHS to reflect on the logistical and structural level of the benefits payable.
In the Italian region, excess weight is more common in men and increases with age, reaching a
maximum percentage in the age group 65-74 years (62%).
Morocco
Diabetes is a serious and common health problem in Morocco. There are some advances in
responding to the challenges of diabetes with some strength in policies on plans, health systems and
monitoring.
The proportion of elderly people in Morocco will be almost equal to that of young people by the
year 2050.
Spain
The foot amputation rate in Spain is near double that observed in other European neighboring
countries. Despite the magnitude of the problem, foot care is only provided for 1 in 4 patients in
Spain.
Diabetes represents a considerable burden for the health system in Spain, accounting for 8.2% of the
total National Health System expenditure.
Although there is a national strategy on diabetes, there are differences in the quality of the diabetes
care and the percentage of costs covered by the different autonomous communities in Spain.
Obesity and overweight are the main causes in near 90% of diabetics. In Spain the prevalence of adult
obesity is 23.2%, this figure reaches 50.2% in diabetics’ adults.
Tunisia
The management of diabetes in Tunisia is not optimal, in fact an estimated 50% of people with
diabetes are undiagnosed: the pathology is among the top five causes of death in the country.
In Tunisia, one in four adolescents, aged 15 to 19, is suffering from overweight or obesity. The
prevalence is similar in both sexes.
According to the National Institute of Statistics (INS), 10.1% of Tunisians were aged 60 years or over
in 2011.
United Kingdom
The proportion of adults with diabetes in the UK is 4% of the population, however, in addition, it is
estimated that a further 630,000 cases are undiagnosed.
The proportion of adults who are obese in the UK is 25%, with over 35% overweight, and obesity is
the second-largest “human-generated” impact on the UK economy, behind smoking.
By 2050 25% of the UK population will be 65 years of age or older, reducing the ratio of people of
working age to pensionable age to less than 3.
These data demonstrated the requirement to address the foot health needs of European and North African
adults through consideration of the whole foot health sector value chain. These data demonstrated the

necessity of addressing the foot health needs of European and North African adults through the
consideration of the whole foot health sector value chain. Moreover, during the project activities, the
SOHEALTHY team worked also on the analysis of the orthopaedic sector in each country as a step further
for a better knowledge of the whole value chain. What emerged is that there is a different approach to the
provision of orthoaedic solutions to the footcare problem involving different actors. National Health
Systems have different rules in each country impacting on the approach to the customer/patient. The most
important commonality is the need to integrate different actors with different background and different
roles in the value chain.
From this state of the art at an industrial and social level, the specific challenges have been derived as a
starting point for the development of a Strategic Research Agenda.
The information about patients’ needs and more than 90 research and technology trends have been
identified accordingly. The following step was to prioritise the technology areas in order to know when they
would be available and arrange them in the short, medium and long term. This task was carried out by the
expert community through the “state of the art” validation forms as well as the different events carried out
throughout the project (the network event held in Manchester and two validation workshops held in Spain
and Tunisia). The resulting prioritised technology areas were also validated by the working group members
during the development of the Strategic Research Agenda. After prioritising the technology trends, the
working groups identified the main footcare sector’s challenges and opportunities, key research and
innovation priorities, industry innovations and key enablers.
The research priorities have been prioritized according to the working groups’ analysis. These five working
groups represent five main research domains which are:
Towards more efficient provision
To improve and develop efficient- for both time and cost- design and manufacturing processes for the
provision of footcare and footwear products to the consumers and wearers defined in the SoHealthy
project.
Towards reduced foot infection
To help reduce infection and hygiene issues in the SoHealthy project populations through the advancement
of microbiology, nano/micro-encapsulation and adhesives for inclusion in footwear and footcare products.
Towards material innovations
To provide suitable materials for use within end-user products in addition to within research and
development in the footcare and footwear sector.
Up-skill providers
Training and education for stakeholders to improve efficiency and processes throughout the provision
process including manufacturers, designers, clinicians, retailers and brands.
End user- driven
To define end user (wearer) needs and characteristics and embed these in all subsequent processes,
establish the efficacy of existing or new technologies/products in user terms, and educate users and
patients in the availability and expected value of devices and treatments.

The research priorities are summarized in the following table. In the document, the description of the
research priorities includes the definition of “What and Why to research”: for each of them clear objectives,
routes to innovation, and actors to be involved to be able to answer to challenges and opportunities. Cross-
cutting issues among the research priorities have also been identified as a way to find complementarities
between the different research areas to be developed for the future. From the research priorities, experts
have identified possible project ideas for collaboration.
Table 1: Research priorities identified by each SoHealthy project’s working groups
WG1: Towards more
efficient provision
WG2: Towards
reduced foot infection
WG3: Towards
materials innovation
WG4: Up-skill
providers
WG5: End-users
drivers
1.1. New 3D
prescription tools for
the prescription of
orthopaedic footwear /
insoles based on
biomechanical and
material essay data
2.1.New microbiology
procedures to detect
microorganisms
colonization for high risk
foot
3.1. New smart
materials with new
appropriate
functionalities for
health care application
4.1. Methodologies for
collection and
formalization of training
needs along the footcare
value chain
5.1. Methodologies for
foot health education
needs per each group of
patients and country
1.2. Cheaper and
portable 3D and 4D
foot scanners
2.2a. New materials with
nanotechnologies that
release antifungal,
bactericidal or
moisturising agents
3.2. Application of
biomechanical
parameters in the
proper selection of
materials for
customised footwear
and insoles
4.2. Integrated training
programmes for
increasing the
integration among
orthopaedic footcare
professionals
5.2. Methodologies to
meet the emotional
needs of users through
co-design technologies,
material and training
provision
1.3. Improved
CAD/CAM tools for the
manufacturing of
custom therapeutic
footwear and insoles
2.2b. New biomaterials
with antimicrobial
properties combined
with novel dressing
materials
3.3. New testing
methods to evaluate
new materials
functionalities
4.3. New ICT based
courses for footcare
professionals to integrate
the footcare chain
5.3. Sensors embedded
in orthotics/ footwear to
measure forces and
pressure for patient
feedback and to asses
function
1.4. Hybrid human-
robot environments in
combination with
Additive Manufacturing
systems
2.3a. Innovative
visualization software for
managing pressure and
temperature information
3.4. New materials with
sensors and biomarkers
as diagnosis and
evaluation tools
5.4. New supportive
tools, applications and
solutions for e-learning
to aide patient
adherence
1.5. Novel supply chain
approaches &
organisational models
for innovative
orthopaedic products
2.3b. New smart textiles
and materials with
sensors to monitor
parameters
3.5. New production
technologies for the
integration of new
materials
1.6. Biomechanical
virtual shoe test bed
based on virtual reality
2.4. International
standardised guidelines
for footwear for the high
risk foot
2.5. To provide
education for patients
with a high risk foot

1. What is the Scope of the Problem?
As mentioned in the H2020 official documents, effective health promotion, supported by a robust evidence
base, prevents disease, improves wellbeing and is cost effective. Health promotion and disease prevention
also depend on an understanding of the determinants of health, on effective preventive tools, and on
effective health surveillance and preparation.
In particular, successful efforts to prevent, manage, and treat foot problems linked to diabetes, obesity and
aging are underpinned by the fundamental understanding of their causes, processes and impacts, as well as
factors underlying good health and wellbeing and application of appropriate treatments.
If effective health care is to be maintained for all ages, efforts are required to improve decision making in
prevention and treatment provision, to identify and support the dissemination of best practice in the
healthcare sector, and to support integrated care and the uptake of technological, organizational and social
innovations empowering older persons in particular to remain active and independent. Doing so will
contribute to increasing, and lengthening the duration of their physical, social, and mental well-being.
All of these activities will be undertaken in such a way as to provide support throughout the research and
innovation cycle, strengthening the competitiveness of the European based industries and the
development of new market opportunities.
Key to this innovation is understanding the nature and current influence of these conditions on the
individual person in addition to on the healthcare system and society as a whole.
1.1 Diabetes
Diabetes Mellitus (DM) is a serious chronic metabolic disease
with important economic, social and human repercussions all
over the world. Due to the alarming increase in new cases, its
chronic complications and high mortality rate, DM has a high
impact on countries’ healthcare costs and patients’ quality of
life.
The International Diabetes Federation, in the sixth edition of
the IDF Diabetes Atlas, estimated that DM caused 4.9 million
deaths in 2014, this means that every 7 seconds a person
died from diabetes. The diagnosis of DM is divided into type 1
and type 2. Type 1 diabetes (T1DM) is an autoimmune
disease where the immune system attacks the insulin producing cells in the pancreas, its prevalence is of
0.2-0.3%. In type two diabetes (T2DM) there is an insulin resistance in combination with insulin producing
cell dysfunction. T2DM affects about 90% of the diabetic population and, as it happens with the majority of
chronic disease, it is caused by risk factors which are mostly preventable. The World Health Organization

and the International Diabetes Federation, have set goals to reduce the rate of amputations by up to 50% in
the following years.
In 2011 there were 366 million people with diabetes and this is expected to rise to 552 million by 2030
(9.9% of the adult population worldwide). Low - and middle - income countries will experience the greatest
increase over the next years. The International Diabetes Federation estimates that, inside Europe, the
growth in the number of people at risk of developing diabetes is relatively small compared to the other
global regions, but the burden will increase from an estimated 7.8% in 2003 to 9.1% in 2025 of the
population aged 20-79 years.
In the European area, there are about 60 million people with diabetes, or about 10.3% of men and 9.6% of
women aged 25 years and over. The prevalence of diabetes is increasing among all ages in the European
area, mostly due to increases in overweight and obesity, unhealthy diet and physical inactivity.
Worldwide, high blood glucose kills about 3.4 million people annually. Almost 80% of these deaths occur in
low- and middle-income countries, and almost half are people aged under 70 years. The World Health
Organisation estimates that diabetes deaths will double between 2005 and 2030.
The most common risk factors for diabetes are:
Overweight and obesity (Body Mass Index, B.M.I. over 25 kg/m2
and 30kg/m2
respectively) have been
estimated to account for about 65-80% of new cases of type 2 diabetes. The risk is a function of the age of
onset and the duration of obesity, weight gain during adult life and the distribution of adiposity, as insulin
resistance has been closely related to abdominal obesity, and this one with metabolic syndrome.
Overweight people run a lower relative risk than obese people, however the fraction of disease attributable
to overweight may be as high as, if not higher than, that due to obesity. This demonstrates the importance
of preventing weight gain and elevated B.M.I in all ranges.
Age: The older a person is, the greater their risk of diabetes. The causes of this are different; one of these is
that insulin resistance increases with age due to changes in total adiposity, decreased lean muscle mass,
changes in lifestyle, etc. However, T2DM is increasing in all age groups and is now also reported among
children and adolescents.

Diet: This is most probably the most important influence factor in T2DM. Eating high levels of refined
carbohydrates and saturated fat contributes to weight gain, thereby increasing the risk of diabetes.
Physical inactivity: Studies have shown that just 30 minutes of moderate exercise a day, five days a week is
enough to promote good health and reduce the chance of developing T2DM.
Others: There are many other complex factors that can influence diabetes (i.e. obesogens such us
endocrine disrupters, some chemicals such us pesticides, etc.). For example today’s hectic lifestyle, where
there are a high number of people suffering from stress and anxiety. Chronic stress triggers an excessive
stimulation of the adrenal cortex to synthesize and secrete cortisol to the blood circulation, what it alters
the glucocorticoid homeostasis contributing that way to the pathogenesis of obesity and metabolic
syndrome. Some studies have demonstrated that an over secretion of cortisol influences the leptin
secretion, which is a hormone that has a play role as a metabolic adaptor in overweight and fasting states.
Diabetes also has a substantial influence specifically on a sufferers foot health. The statistics reported in
the scientific journal “The Journal of Clinical Investigation” shows that:
• Ulcers in the feet occur in 15% of diabetics
• 84% of amputations of the lower limbs in diabetics are specifically related to the development of
foot ulcers
Diabetic neuropathy occurs in about 30% of diabetic patients with pains like cramp mainly nocturnal, in the
calf muscles, decreasing decrease in sensation in the lower limbs and the development of ulcers in the foot.
As a consequence of neuropathy the patient may present with a so-called "diabetic foot", determined by
vascular and nerve injury with severe bone deformations and disorders of the terminal blood supply of the
foot. The diabetic foot syndrome is a chronic complication of the DM, which considerably reduce the
patients’ quality of life. It represents a major problem in the health care of diabetic patients. One of its
most serious complications are lower extremity amputations, of which 85% of them are preceded by an
ulcer. In addition, the rates of recurrence of foot ulcers is greater than 50% within 3 years. Complications
related to the diabetic foot results in the greatest number of hospital admissions and about 15% of
diabetics will face a foot ulcer that will require medical care during their life time.
Patients with diabetic foot syndrome need specially designed therapeutic footwear or inserts intended to
reduce the risk of skin breakdown. The primary goal of therapeutic footwear is to prevent complications,
such as: strain, ulcers, calluses, or even amputations for patients with diabetes and poor circulation. This
can be achieved through offloading techniques and the reduction of pressures on the diabetic foot skin.
The shoes may also be equipped with a removable orthotic. The diabetic shoes and customized insoles
work together as a preventative system to help diabetics avoid foot injuries and improve mobility. This
illustrates that footwear is fundamental in influencing their foot health status particularly in patients with
T2DM.
1.2 Obesity and overweight
Obesity is a dysfunction of the body’s weight control system that adjusts the body’s fat reserves to beyond
its optimum size. The most important cause is the adoption of unhealthy eating habits, in preference to

saturated fats and simple carbohydrates, and inactive lifestyle. Obesity is a complex reality where not only
biological factors, but also social and cultural factors are influential. The worldwide prevalence of obesity
nearly doubled between 1980 and 2008. According to country estimates for 2008, over 50% of both men
and women in the WHO European Region were overweight, and roughly 23% of women and 20% of men
were obese. WHO warned about the need to establish the necessary measures to prevent what is
considered the real health epidemic of the 21st century.
Based on the latest estimates in European Union
countries, overweight affects 30-70% and obesity affects
10-30% of adults. Estimates of the number of
overweight infants and children in the WHO European
Region rose steadily from 1990 to 2008. Over 60% of
children who are overweight before puberty will be
overweight in early adulthood. Childhood obesity is
strongly associated with risk factors for cardiovascular
disease, type 2 diabetes, orthopaedic problems, mental
disorders, underachievement in school and lower self-
esteem.
It is known that obesity and sedentary lifestyle represent risk factors to health associated with the onset of
numerous chronic diseases including foot problems.
In contrast, a healthy diet, a normal weight, moderate and continued exercise over time reduce the risk of
several degenerative and fatal conditions. In particular reducing the risks associated with diabetes,
affecting blood lipids, blood pressure, thrombosis, glucose tolerance, insulin resistance and other metabolic
changes.
As regards as foot health, it is important to design and manufacture suitable fitting footwear in order to
provide comfortable footwear to this population with adequate volume to contain their feet and ankles in
the case of winter footwear. Additionally this could improve their foot health by reducing the risk of
deformity or tissue injury through ill-fitting footwear. This will improve the comfort of the wearer and may
also increase their stability or likelihood of wearing footwear which is too long for their foot length and thus
could potentially reduce falls risk.
1.3 Elderly
Ageing is one of the greatest social and economic challenges of the 21st century for European societies. It
will affect all EU countries and most policy areas. By 2025 more than 20% of Europeans will be 65 years of
age or over, with a particularly rapid increase in numbers of adults over80 years.
Because older people have different healthcare requirements, health systems will need to adapt so they
can provide adequate care and remain financially sustainable. Co-morbidities within this population
increases the demand they place on local services e.g. podiatry services if available. Vascular complications,
acute metabolic decompensation, the negative effects of drug treatment, as well as the effects on eating
behavior and lifestyle, often lead to different levels of disability and/or handicap. These changes can lead to

negative effects of rebound on susceptibility to other forms of co-morbidity, self-sufficiency and quality of
life.
Ageing is also related to diabetes and obesity, so that
increasing age is a risk factor for the development of
diabetes. Several studies have demonstrated that the
incidence of T2DM increases significantly with age,
with 20%-25% of prevalence in people aged over 65
years.
By 2050, diabetes cases are projected to increase
four-fold in patients older than 70 years. Diabetes in
the elderly is responsible for significant morbidity and
mortality.
Regarding older people’s foot health, to highlight the importance for this group of population of wearing
correct fitting footwear, adapted to their needs. This is important not only for increasing comfort
perception, but also to prevent falls, which is one of the leading causes of both fatal and nonfatal injuries
that could lead to death, as well as foot problems and injuries. One out of three older adults (those aged 65
or older) falls each year and footwear can be designed to prevent a high percentage of them.
1.4 Diabetes, obesity and ageing in the MENA region
According to the International Diabetes Federation (IDF), in the sixth edition of the diabetes atlas, 80% of
people with diabetes live in low and middle-income countries and this tendency is growing. There is a high
incidence of Diabetes in the MENA region where one in ten adults have the disease. The situation will be
even worse in 2035, with an increase of 96% the number of diabetics (67.9 million of diabetics). Therefore,
the growing prevalence of diabetes across the Middle East and North Africa poses major challenges for the
governments in these countries and their respective health systems.
A systematic review carried out in the north Africa region in 2013, reported that the availability of data on
the prevalence of diabetes in this area over the past twenty years is limited and the reviewed studies used
different methods to diagnosed diabetes, what made it difficult to describe trends of diabetes prevalence
over time. The review states that undiagnosed diabetes is very common, with high variations in prevalence
between individual countries. Additionally, within countries, prevalence is significantly higher in urban
areas than in rural areas, and higher in people with higher socioeconomic status. In Egypt, for example, the
prevalence of diabetes was 20% in the urban area.

The prevalence of undiagnosed diabetes was 75% in Tunisia. This difference between the urban and rural
areas as well as the socioeconomic status is also seen in the obesity prevalence, which ranged from 56% in
men with higher socioeconomic status in urban Egypt to 6% in men in rural Egypt.
Figure 1: Diagnosed/undiagnosed in North Africa region, in 2014.
IDF diabetes Atlas, sixth edition
According to WHO figures, in Morocco, the number of obese people was 22.3% of the total population,
28.9% in Egypt, 24.8% in Algeria and 27.1% in Tunisia. The difference between males and females is, in
many cases, very high, for example in Egyptian males the prevalence of obesity was 20.3% and in females
37.5%.
Figure 2: Overweight and obesity in North African countries. *Age-standardized adjusted estimates.
Source: Global Status Report on non-communicable diseases, WHO 2014
The prevalence and incidence of obesity and diabetes in the North African region will increase due to an
increasing life expectancy and urbanization, due to factors such as decreased physical activity and
unhealthy diet patterns.
Diagnosed and undiagnosed diabetes cases in the
North Africa region (2014)
0,00
1000,00
2000,00
3000,00
4000,00
5000,00
6000,00
7000,00
8000,00
Diabetes Cases (20-
79) in 1000s
704,35 1552,17 7593,27 1649,07
Undiagnosed
diabetes cases (20-
79) in 1000s
352,58 776,08 3796,64 824,54
Tunisia Morocco Egypt Algeria

Figure 3: Diabetes national prevalence and related deaths in North Africa Region.
Source: IDF diabetes Atlas, sixth edition.
References
 H2020: Council Decision establishing the Specific Programme Implementing Horizon 2020 - The
Framework Programme for Research and Innovation (2014-2020)
 International Diabetes Federation. IDF Diabetes atlas. Sixth edition. 2013.
(www.idf.org/diabetesatlas)
 Bos and Agyemang: Prevalence and complications of diabetes mellitus in Northern Africa, a
systematic review. BMC Public Health 2013 13:387.
 Bouguerra R., Alberti H., Salem LB., Rayana CB., Atti JE., Gaigi S., Slama CB., Zouari B., Alberti K.: The
global diabetes pandemic: the Tunisian experience. Eur J Clin Nutr 2007 Feb, 61(2):160–165.
 Global Status Report on non-communicable diseases 2014. World Health Organization. 2014

2 Country Overviews
Country overviews section provides an insight into the situation within the SoHealthy project partners’
countries: Italy, Morocco, Spain, Tunisia and United Kingdom, as regards as obesity, diabetes and ageing
and the situation of the orthopaedic footwear sector in each of these countries. Thus, it provides a picture
about the dimension of these problems and the status of the footcare sector and therefore, this section is
linked with section 6, which is about country-sector specific recommendations.
2.1 Italy
2.1.1 Diabetes
According to ISTAT data, in 2013 in Italy there was a prevalence of diabetic people equal to 5.4% (5.3% in
women, 5.6% in men) amounting to more than 3 million people, with an increasing trend over the last
decade.
Figure 4: Diabetic Trend 2000-2013 (ISTAT data)
The share of diabetic people increases with age up to proportion of approximately 20% in people over the
age of 75 years. While for people with less than 54 years, the share is below the average, for people above
55 years the percentage of diabetic people is very high.
Figure 5: Diabetic people in Italy (ISTAT data) - and for geographical area

Looking at the distribution of the diabetic people in the Italian territory, the prevalence is lower in the
Northern Regions at 4.6%, compared to 5.3% in the Centre and South Italy 6.6%. Research estimates that
the lifetime incidence of foot ulcers within the diabetic community is around 15% and may become as high
as 25%.
And how long from the diabetes diagnosis?
It is known that patients with diabetes have increased risk of lower limb amputations, and comorbidities
such as ischemic heart disease, blindness and kidney failure. A study on 110,637 people with type 2
diabetes shows that after 10 years of disease the incidence of complications is doubled.
Complications At diagnosis (%) Increase year risk Risk after 10 years
Beginning risk
(years from diagnosis)
Oculars 16 2.1 37 7.6
Renals 6.3 0.63 12.6 10
Diabetic foot 18.4 1.4 32.4 13.1
Cardiovascular 17.6 1.1 28.6 16
Table 2: Complication due to diabetes (Source: www.riparazionetissutale.it )
The percentage of patients who have a pathology of the foot is about 18.4% and is nearly doubled after 10
years. About 50% of amputations within Italy involve the limbs of diabetic patients.
Nationwide diabetes:
Diabetes is among the main priorities of the current National Health Plan. Italy has adopted national
declarations on diabetes and has joined international diabetes initiatives. The country has been
implementing a national diabetes plan since 2012 and a national plan for NCDs covering diabetes was
adopted in 2013.
These plans include primary prevention, diabetes screening and diagnosis, care provision, support for self-
management and secondary prevention. The Ministry of Health reported that further areas are covered by
these plans, including information systems to collect cost and epidemiological data and diabetes research,
although other stakeholders did not confirm this. The Ministry of Health, professional and patient
organizations and industry representatives were consulted in the development of these plans. Due to the
decentralized nature of the Italian health system, the plans are submitted to regional health authorities to
be translated into regional actions. The annual budget for the diabetes and NCD plans is unknown. Their
strongest sources of information was a national situation analysis and international strategies and
guidelines. Monitoring and implementation are insured via a monitoring system and evaluation of key
milestones or targets, relative to a detailed baseline study and a list of measurable indicators for each of
the plans’ objectives.
“Without prevention, early diagnosis, and improved treatment, the clinical, social, and economic
burden related to Diabetes mellitus will soon become unsustainable”

According to some stakeholders, while these plans are inclusive and benefit from strong political support,
they are affected by the current economic crisis, which limits financial, human and technical resources.
Other information also suggests that the national diabetes plan may not be implemented to the same level
in the different regions.
2.1.2 Overweight and obese
For the year 2012, ISTAT notes that in Italy the proportion of overweight was 35.9% of the adult population
(male 44.6% and female 27.6%) while obese people was 10.6% (male 11.5% and female 9.6%)
corresponding to approximately 4 million of people. In particular in the South of Italy, the proportion of
obese and overweight is highest (11.9% and 39.6%).
In 2009-2012, data from “Sistema PASSI” showed an increase in the older age group 50-60 years, with
prevalence of 40% overweight and 16% obese among men and women 40% and 11%.
The survey “Okkio alla salute” conducted by the ISS-CNESPS in 2008-2012 on an age group between 6 and
17 confirmed serious levels of excess body weight with 22.1% of overweight children and 10.2% obese boys
showing, for example, a higher frequency of overweight and obese in 11 years old (29.3% males and 19.5%
females) compared to the 15 years old (25.6% in males and 12.3% in females).
This study also reported that children up to 15 years of age undertake less physical activity (47.5% in males
and 26.6% females) compared with those of 13 years of age (50.9% in males and 33.7% in females).
Figure 6: Overweight and Obese in Italy (ISTAT data, 2012) - Overweight-obese in teenagers (ISTAT data, 2009-10)
2.1.3 Elderly
Italy is among the countries with the highest rate of longevity and therefore an aging population. This is
demonstrated by the data collected by Istat, where in a total of 59.1 million inhabitants, 11.8 million are
over 65, a proportion of 19.9% of the total population, which is estimated to reach the 26.5% by 2030.
“The proportion of overweight is the 35.9% of the adult population while obese people are the 10.6%”

From 1980 to 2005 the number of people over 65 increased by 50%, while that of octogenarians by over
150%. This demonstrates a trend in continuous and substantial growth.
Given the considerable presence of seniors nationwide, we can now ask what their state of health in old
age. In this case, the ISTAT report shows that, among the population of people over 65 years of age, 40%
suffer from at least one chronic disease, 18% have functional limitations that affect their daily lives
(disability), 68% of people with disability have at least three chronic diseases, and 8% are confined to their
homes. The increased survival and the high prevalence of multi-morbidity and frailty in the elderly have led
inevitably an increase of disability with age. Also noteworthy is that, in relation to the increase of the
population, the ISTAT forecast on the number of disabled people for the next 20 years is an increase of 65-
75%.
Adults over 65 years of age are the prime users of healthcare resources, which has led the NHS to reflect on
the logistical and structural level of the benefits payable.
Figure 7: Percentage of over 64 in Italy, in 1996 and 2013
Relation between the three target groups
In Italy of over 3 million people affected by type 2 diabetes, two-thirds are over 65, and 25% are over 75
years of age. The population of elderly adults is expected to grow due to the aging population, therefore
“Over 65 then turn out to be the biggest users of healthcare resources, which necessarily has led the
NHS to the need for a serious reflection about rethinking to logistical and structural level of the
benefits payable”
33
29
16,8
21,2
27,4
24,1
20,9
27,7
0
10
20
30
40
Age:65-69 Age:70-74 Age:75-79 Age:over 80
%
PercentageofOver64
1996 2013

requiring an increase in attention not only relating to the treatment and care of the elderly with diabetes,
but especially on the prevention of complications related to the disease.
There are more and more clear evidence of how diabetes is associated with reduction in psychophysical
performance and chronic disability, and how this can lead to severe disability and social disadvantage in the
elderly population.
Figure 8: Number of diabetics in Italy.
Among seniors over 64, the percentage of overweight people is 42% while that of obese is 15%. Excess
weight is more common in men and increases with age, reaching a maximum percentage in the age group
65-74 years (62%) and then decreased in 75-84 (56%) and reach a value even lower in the over 85 or older
(44%).
Above 65 years of age, body mass index is subject to changes due to both biological and pathological
factors. Progressively, each age group above 65 years of age has fewer percentage of people overweight
individuals (on average 5% of initial weight in a year), as represented in the figure below.
“Excess weight is more common in men and increases with age, reaching a maximum percentage in
the age group 65-74 years (62%)”

Figure 9: Excess weight in Italy, by sex and age (Asl Pool ‘Passi 2010-13’ and
‘Passi d’Argento 2012’)
In the adult population (18 years of age and over) the prevalence of diabetes is 5.8%, among obese adults
prevalence increased to 15.2%, an increase of 5% compared to 2001. This proportion increases with age up
to 29.9% among those aged 75 years of age and over, again increasing, compared to 2001, by 8%.
Figure 10: People with diabetes for body mass index and gender distribution (ISTAT
2011).
2.1.4 The orthopaedic footwear sector in Italy
The orthopaedic footwear market in Italy is regulated by the National Nomenclature, dated 1999. The
Nomenclature gives the guidelines for the orthopaedic footwear market; it defines the typologies of shoes
distributed and reimbursed to the patient that can benefit of a medical prescription:
1. Standard orthopaedic shoes
2. Customized orthopaedic shoes
The normative also defines the lead-times for the supply of the orthopaedic shoes (maximum 40 days), the
warranty and the renewal of the medical prescription for each patient (1 year for customized shoes and 6
months for standard ones).
Production Process of orthopaedic footwear
The production process of orthopaedic shoes is deeply affected by the rules given by the Nomenclature,
and there is a specific path that all the supply chain actors have to respect to produce and distribute shoes
as a medical device reimbursed from the Minister.
In case of customized shoes, structures and materials are chosen to address to specific functional
requirements (as explain in the following paragraph).
The steps identified and the actors involved in the production process of customized shoes are:

1. Medical Prescription – Doctor and customer
2. Price estimation – Orthopaedic provider and customer
3. Permission and approval – Orthopaedic provider and National Health Service
4. Foot Measurement – Orthopaedic provider and customer
5. Design and Production - Orthopaedic provider and suppliers
During step 5, the orthopaedic technician starts to design the shoes and plantar and then produce both of
them, to address the needs collected from the patient and the medical prescription according to the
following flow:
- Design of the shoes consistently with the specific requirements of the customer
‐ Creation of the personalized last (plastic or wood)
‐ Creation of shoe funds
- Creation of production patterns basing on patient’s measurement
‐ Creation and cutting of the upper
‐ Stitching and manual assembling of the orthopaedic shoes
6. Trial with the patient – Orthopaedic provider and customer
7. Delivery and Testing – Orthopaedic provider and customer
Historically, the production of customized orthopaedic shoes is handmade, and the craftsmanship is an
important value-added for an orthopaedic footwear producers to obtain the best quality for the shoes and
the best results from the patients. Nowadays, in the analyzed companies roughly 30% of these shoes are
produced using milling machine for last production. Technologies could be involved in different stages of
the process: measurements can be taken using 3D scanners, instead of the traditional foam; the plaster
cast technique is anyway used for the most serious case. Information from 3D scanners can be sent directly
to the milling machine for the production of the last. Thanks to innovative technologies, efficiency
increased, lead-time for last creation decreased and precision of the production process improved.
Customization Process
The customization process is the most important in the production of the orthopaedic shoes, particularly
for the requirements side to answer effectively to the patients’ needs. All the customized shoes are
adapted according to customer’s measurement. We identify most important categories of customization
according to the checklist used by the orthopaedic providers to collect customer’s functional requirements
like: circumferences (patient’s measurements), upper – height, spurs, padding and need of an external
spring; Tips – type; Lacing – type; Toe – structure; Sole – structure and material; Fund – type, etc.
In addition to the above categories, customers can chose their favorite model and the materials for the
production of their orthopaedic shoes, coherently with their pathology and functional requirements.
Moreover, the orthopaedic technician also collects other qualitative observation from the patient, if they

have pain and which kind. Then, merging patient’s measurement and requirements with medical indication,
the orthopaedic technician designs the specific shoes for the customer according to the models available.
For what concern the standard orthopaedic shoes, both structure and materials are chosen by the
producers to better address customer’s functional requirements, based on their different pathologies. The
shoes are produced according to data collected year by year from past customers and to detailed studies of
the pathologies and functional requirements related, to obtain the best corrective effect from the using of
those shoes.
Supply chain configuration
The supply chain of the orthopaedic producers and providers is organized to compress at the best response
lead times and to improve quality of the products. Considering that patients show specific and complex
needs due to their particular condition, partners should guarantee the best level of service in terms of
response time and quality of materials. Important supply network actors are: raw material suppliers and
technologies suppliers.
Generally, orthopaedic producers establish partnerships with the latter, to improve and innovate their
production processes in terms of lead-time and quality of their products.
Costs are not a critical issue for the orthopaedic providers because of the fixed reimbursement defined by
the government. Neither a particular attention is given to the organization of the market side, because of
the monopolistic advantage that orthopaedic providers can benefit in their territory, together with the
continuous needs that patients show in the distribution of orthopaedic shoes and the reimbursement by
the National Health Service (NHS) paid only to the orthopaedic shops registered at the ministry.
Generally orthopaedic providers do not outsourced any phase of production; if they do not produce the
shoes inside their company, they buy the final product from another supplier according to available
standard models.
Number of manufacturers of orthopaedic footwear
In Italy, the provision of orthopaedic footwear is based on a national register at the Ministry of Health.
Currently the total number of producers is 1.363. The first 6 regions for orthopaedic footwear provision are:
Lombardia, Piemonte, Lazio, Emilia-Romagna, Tuscany, Veneto and they represent the 60% of the total
provision.

Figure 11: Manufacturers to Measure of Orthopaedic Area (Ministry of Health, August 2008)
Cost of a pair of orthopaedic shoes
The application and supply of orthopedic footwear is made by the orthopedist enabled.
For orthopedic shoes means: orthopedic shoes in ready-made and custom-made orthopedic footwear.
 Orthopaedic shoes in ready-made:
They are designed to diseases and physical limitations of mild to moderate intensity. They are built in small
batches using properly studied forms. Materials and patterns are specific to different functional limitations
they address.
The models low, high and sandal with high or low buttresses in production phase have similar difficulties, so
it is not necessary to differentiate them. These shoes are always supplied in pairs. The technician at the
time of supply to the patient will proceed to customization by making proper adjustments to the sole
and/or to the heel, and more that will require adaptation to the orthosis with which they will be matched.
The cost of orthopaedic shoes in ready-made depends on the type of the model, on the size and on the
type of predisposition (for plantar, for particular diseases etc.). It starts from a minimum of 80.05 euro up
to 190.11 euro, but which can increase taking into account any additional (from 8,78 euro to 124.93 euro).
 Custom-made orthopaedic shoes:
It consists of a shoe constructed specifically tailored to accompany the model of orthopedic shoe built for
the deformed limb. This shoe is not suitable to contain orthotics and corrections.
Also in this case, the cost of the shoes depends on the type of the model, on the size and on the type of
predisposition (for plantar, for particular diseases etc.). It starts from a minimum of 140.58 euro up to
385.43 euro, but which can increase taking into account any additional (the same as the previous case).
References

 Ministry of Health, Department of public health and innovation. Directorate General of Prevention.
Report 2014: “Stato delle conoscenze e delle nuove acquisizioni in tema di diabete mellito”
 Changing diabetes, Italian Barometer Diabetes Forum, Second Report, 2010 - Measure, Compare,
Improve; Stefano Del Prato, Mario Pappagallo
 Il portale dell'epidemiologia per la sanità pubblica, Sistema sorveglianza Passi:
http://www.epicentro.iss.it/passi/dati/sovrappeso.asp
 Okkio alla salute – Senato della Repubblica, , XVII Legislatura, Relazione sullo stato delle conoscenze
delle nuove acquisizioni scientifiche in materia di diabete mellito, con particolare riferimento ai
problemi concernenti la prevenzione.
 Dinamica di domanda e offerta di dispositivi medici nel Veneto: policy e possibili scenari evolutivi, a
cura del CERGAS Centro di Ricerche sull’Assistenza Sanitaria e Sociale Università Commerciale L.
Bocconi;
 How to address the needs of specific target groups: a comparison between fashion and orthopaedic
footwear supply chains, Valentina Franchini, Rosanna Fornasiero, Prof. Andrea Vinelli.
 Diabetic Foot, website: http://www.my-personaltrainer.it/benessere/piede-diabetico.html
 Diabetic Foot, website: http://www.infermierimilano.it/piede-diabetico.html
 Quotidiano sanità ISTAT: studi e analisi, la disabilità in Italia -
http://www3.istat.it/dati/catalogo/20100513_00/arg_09_37_la_disabilita_in_Italia.pdf
 Italian Society of Geriatrics and Gerontology, Clinic Section: “Gestione del paziente anziano con
diabete mellito. Tipo 2: esperienza dallo studio osservazionale” G. Gerontol 2009;57:267-274
 Diabetic Foot- tissue repair: Italian website on chronic skin lesions.
http://www.riparazionetessutale.it/piede_diabetico/introduzione.html

2.2 Morocco
2.2.1 Diabetes
In Morocco, the last national estimation indicated that about two million people have diabetes, of which
10% are T1DM and 90% T2DM. From 5,000 to 7,000 amputations occur each year related to diabetes, the
real statistics might be much higher, especially in rural areas due to the lack of awareness and support as
well as management.
Figure 12: Diabetes in adults by age. Source: IDF Diabetes Atlas, Update 2014
The figure describes which age groups in the population have the highest proportions of diabetes. Looking
at the prevalence of diabetes shows that the prevalence is lower in Morocco compared to the Middle East
and North Africa.
Diabetic foot problem
Relating to problems of diabetic foot, some statistics reported show that:
 3 to 10% of diabetics suffer from feet problems. Despite this situation, in Morocco there are
only 20 podiatrists for a total population of nearly 33 million people.
 1/15 of diabetic feet will be amputated.
 ½ amputations could have been prevented by early and adequate treatment.
 50% of non-traumatic amputations are diabetic.
 10% of diabetics undergo amputation, 50% in the toes.
 50% of patients who underwent amputation will have another within 4 years.
 20% of the beds of a diabetes service are occupied by patients with feet lesions.

The increased number of people with diabetes in Morocco reflects current global trends and the need of
undertaken urgent measures that control this situation.
Diabetes is a serious and common health problem in the country. Morocco is making some advances in
monitoring.
The member association reports that, there is little coordination between government and civil society in
regards diabetic foot. Plans and policies should be fully implemented to strengthen the response.
According to national anthropometry survey conducted by High Commission for Planning (HCP) in 2011,
there is an incidence of pre-obesity increased in 10 years (2001-2011) from 27% to 32.9% (from 29.2% to
34.9% in urban areas, from 24.1% to 29.5 % in rural areas). The same trend is found among both men
(23.9% to 30.8%) and women (29.9% to 34.7%). Overall, the number of adults in pre-obesity increased in 10
years from 4.5 to 6.7 million.
Regarding the incidence of overweight and morbid obesity, it affected 3.6 million adults in 2011,
representing 17.9% of the population (21.2% in urban areas, 12.6% in rural areas).
This is higher in women at 26.8% prevalence in comparison to 8.2% in men. Urban women have a higher
prevalence with 31.3% of them being defined as overweight or obese, in comparison in rural women there
is a prevalence of 18.5%.
- In total there are 10.3 million Moroccan adults with obesity including 63.1% of women.
- In 10 years, severe and morbid obesity increased by an average of s 7.3% per year between 2001
and 2011.
- Less than 46% of Moroccan adults do not suffer from obesity or pre-obese.
Data on measured heights and weights indicate that the prevalence of obesity has increased among the
Moroccan population over the past 15 years. As aforementioned, excessive weight is more prevalent in
urban than in rural areas, varies by geographical region, and additionally is positively associated with age
“Diabetes is a serious and common health problem in Morocco, that is making some advances in
monitoring”
“Data on measured heights and weights indicate that the prevalence of obesity has increased
among Moroccan population over the past 15 years”
“3 to 10% of diabetics develop diabetic foot syndrome. Despite this situation, in Morocco there are
only 20 podiatrists for a total population of near 33 million people”

and negatively with education level. The increasing prevalence of obesity poses challenges for researchers
and policy makers.
Figure 13: Incidence of overweight and morbid obesity, in 2011.
Source: High Commission for Planning (HCP)
2.2.3 Elderly
Morocco’s elderly population stands at 2,500,000. The percentage of elderly population stood at 9% in
2014, it is estimated to be 11.1% of the population by 2020 and 20% in 2040. According to the CERED
(population research center), the proportion of elderly people in Morocco will be almost similar to that of
young people by the year 2050. This can be explained by the increase in life expectancy figures (which
stood at 65, even 70 years of age in 2004, resulting in a new classification of elderly population brackets:
old, quite old and very old). Old people represent 9% of the urban population currently.
A Moroccan study reported that the prevalence of diabetes is 9% of those older than 20 years. In addition,
if we consider the age beyond 50 years, the prevalence exceeds 14%.
2.2.4 The orthopaedic footwear sector in Morocco
The Moroccan shoes industry is the main activity of leather sector and has more than 360 industrial units
producing about 75% of the total sector value. It is characterized by a wide variety of manufactured items
and ranges such as: shoes for men, women and children, professional shoes, safety shoes...
Talking about orthopaedic shoes, unfortunately there is an absence of orthopaedic specialists such as
pedorthists who are highly trained professionals in the design, fit and function of shoe and orthotics. They
can also provide technical plan to a shoemaker in order to make appropriate footwear. However, there are
about twenty podiatrists throughout the country who were trained in Europe. In this case podiatrist
diagnoses the patient with foot problems and then provides the patient with a prescription including
The proportion of elderly people in Morocco will be almost similar to that of young people by the year
2050.

specific needs. This order is delivered to the shoemaker and the podiatrist follows up the manufacture
process.
Additionally, there is a lack of national standardization in the orthopaedic shoes production. Regarding the
cost, the price of a pair of orthopaedic shoe will cost between 100 euro and 300 euro.
Concerning reimbursement, the National Social Security Fund does not support orthopaedic shoes, but
private insurance is available from which the reimbursement depends on the contract between the patient
and the insurance agency. In private insurance case, the reimbursement does not exceed 70%. In contrary,
the foot costs are generally reimbursed.
References
 High Commission for planning (HCP): http://www.hcp.ma/
 Estimation of direct and indirect cost of diabetes in Morocco, W.Boutayeb, M. E. N. Lamlili, A.
Boutayeb, Saber Boutayeb. PP. 732-738
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=34768#.VQFXYo4Q3CM
 Obesity threatening 10 million Moroccans, Al Arabiya news
http://english.alarabiya.net/articles/2012/11/26/251898.html
 Rguibi, M., and R. Belahsen. "Prevalence of obesity in Morocco." Obesity reviews 8.1 (2007): 11-13
 Type 2 diabetes in Belgians of Turkish and Moroccan origin, H.Vandenheede and P.Deboosere. Arch
Public Health. 2009; 67(2): 62–87 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463009/
 Ministry of health: http://www.sante.gov.ma/Pages/Accueil.aspx
 World Health Organization (WHO): http://www.who.int/en/

2.3 Spain
2.3.1 Diabetes
In Spain, the incidence of T2DM is of 8/1000 persons/year and the prevalence in Spain is 13.8% of the adult
population, which is expected to rise to 14.39% in 2035. In 2012, there were 9,987 deaths in Spain due to
diabetes, of which 4,207 were males and 5,780 females. The total number of diagnosed diabetes cases
from 2011 to 2012, in thousands, was of 2690.7 cases. The following graph shows this indicator divided by
sex and age:
Figure 14: No. diagnosed diabetes cases in the last 12 months. National health survey (2011-2012).
Source: INE, Spanish National Statistics Institute.
According to the Di@bet.es study, which was the first study that provided information on the prevalence of
DM and impaired glucose regulation in Spain by means of a national, cross-sectional, population-based
survey conducted in 2009-2010, the prevalence of known diabetes was of 8.1% in and around 6.8% of
patients with T2DM had not yet been diagnosed (unknown diabetes). This study stated that the prevalence
of DM was different in each geographical region, except in big metropolitan regions. The population’s level
of education is also important in the epidemiology of diabetes, as the lower level of education and
socioeconomic status are, the higher incidence of type 2 diabetes is. Actually, there is 28% increased risk of
having DM in people with low educational level. According to these data, it is of high importance that the
patient with DM has an active role in the management of the disease since he/she is diagnosed in order to
improve the understanding of the disease and consequently, prevent chronic complications of diabetes.
Related to this, the industry and, in our case, the footcare industry, can also have an active and important
role, as it can work together with clinicians and patients in order to achieve a higher involvement of
patients in the whole process since the patient is diagnosed and therefore a higher patients’ adherence to
the diabetes treatment.

In a Spanish study with 7,371 patients with T2DM, 14% of them developed diabetic foot syndrome. A high
number of studies confirm that the incidence of amputation is high in patients with diabetic foot. For
example, in Andalusia (Spain), the incidence from 1998 to 2004 was of 3.4 per 1000 patient-year. Therefore
the right management of a diabetic ulcer is crucial. A recent study carried out by the Spanish Group on The
Diabetic Foot (SGDF) has demonstrated that the foot amputation rate in Spain is near the double than
observed in other neighboring countries. And this tendency is growing, what reveals the need of
undertaken urgent measures to manage this condition.
The International Working Group on the Diabetic Foot recommends the creation of multidisciplinary teams
for managing diabetic ulcers, as they predict that between 45% and 85% of amputations can be avoided by
adopting a multidisciplinary approach. It is surprising that despite the magnitude of the problem, foot care
is only provided for 1 out of 4 patients in Spain and that podiatrists are not in included in the public health
system to provide preventive foot care, as the number of multidisciplinary Diabetic Foot Units is very low.
This highlights the need of undertaking new and improved measures by the Spanish National Health System
that lead to a better management of the diabetic foot in Spain.
Costs of diabetes care
The Spanish National Health System is the agglomeration of public health services that has existed in Spain
since it was established through and structured by the Ley General de Sanidad (the "General Health Law")
of 1986. It is administered by 17 regions, which are coordinated by the national government and fully
financed by the general tax fund. As a percentage of GDP, total health expenditure in Spain is 9.5% in the
year 2009 (71% public and 29% private). Public health expenditure represents 7.0% of GDP and per capita
spending is €1,604.
With regards to diabetes care, Spain offers a good health coverage system with well-developed care free at
point of delivery. Since 2007, there has been a national diabetes plan providing general guidelines to
stimulate the implementation of regional programs for prevention, early diagnosis and efficient treatment,
as well as research. Some regions additionally have their own regional prevention plans.
The information on cost of diabetes in Spain has to be updated. In addition, more information about the
quality of care of diabetes in Spain is needed. The Spanish diabetes cost studies estimates that, in 2009,
€5.1 billion for direct costs along with €1.5 billion for diabetes-related complications and labor productivity
losses represented €2.8 billion. This is around 8% of the total National Health System expenditure.
“The patient should have an active role in the management of diabetes, also the industry, in order to
get a higher patient’s adherence to the diabetes treatment and therefore, a lower risk of developing
diabetes chronic complications, as diabetic foot is”
“The foot amputation rate in Spain is near double than observed in other European neighbouring
countries. Despite the magnitude of the problem, foot care is only provided for 1 out of 4 patients in
Spain”

According to the SECCAID study (Spain estimated cost Ciberdem-Cabimerin Diabetes - 2013), in 2013
patients consumed 8.2% of total public health expenditures. Another study published in 2013 estimated a
cost of €5.1 billion for direct costs, with €1.5 billion for diabetes-related complications worldwide. Labor
productivity losses amounted to €2.8 billion. The annual cost per diabetic patients averaged close to €1,660
for direct costs and €916 for productivity losses, with significant differences between patients with and
without micro and macrovascular complications.
To highlight that, although diabetes is a priority area in all autonomous Communities, only 31.6% had a
diabetes action plan in 2006.
Regarding the diabetic foot, to highlight that 10-15% of diabetic patients develop foot ulcers at some point
in their lives and foot related problems are responsible for up to 50% of diabetes related hospital
admissions. As aforementioned, patients with diabetic foot syndrome need specially designed therapeutic
footwear or inserts intended to reduce the risk of skin breakdown: footwear is fundamental in influencing
foot health status.
Despite the importance of this fact, each autonomous community of Spain covers different percentages of
the total cost of a pair of diabetic or customized shoes, and the insoles are in general not covered by the
National health system. This means that a Spanish citizen will pay more or less money for a pair of
orthopaedic shoes depending on the community he/she lives. Unfortunately, this also happens with the
quality of the diabetic foot care received, as the diabetic foot units in Spain are comprised by different
specialties in each case and have different population coverage. In addition, not all autonomous
communities have a diabetic plan.
For example, since 2012, the Valencian Health System covers, in the case of big feet deformities, 1 pair of
customized orthopaedic shoes per 2 years. According to the Valencian Health System, the estimated cost of
a pair of customized shoes is 379.47 euro in total, where the orthopaedic company receives 137.39 euro
from the Valencian Health System, and the patient receives 206.08 euro. However, according to
orthopaedic footwear manufacturers, this amount does not cover the production cost, as the estimated
production cost is more than 140 euro (depending on the case). As a consequence, the orthopaedic shops
have to increase the price of sale to public, being this price around 600 euro. Therefore, the patient finally
defrays more than 65% of the total price (more than 360 euro), which is, in most cases, unaffordable for a
high percentage of the population, in particular, old age pensioners.
In the case of diabetic foot, arthritic feet, neuropathic foot, and post-foot surgery, the Valencian
Community covers one pair of orthopaedic shoes every 2 years. This health system estimates the cost of a
pair of diabetic shoes is 96.35 euro in total, where the orthopaedic company receives just 24.14 euro, and
“Diabetes represents a considerable burden for the health system in Spain, with 8.2% of the total
National Health System expenditure”
“Although there is a national strategy on diabetes, there are differences in the quality of the
diabetes care and the percentage of costs covered by the different autonomous communities in
Spain”

the patient receives 36.21 euro. However, as it happens with customized orthopaedic shoes, this amount
hardly covers the production costs, as the price of sale to public ranges from 90-200 euro. So, in this case,
the patient defrays 60% - 80% of the total price (more than 60 euro).
As a consequence of the high price the patient has to pay, a large number of them decide not to purchase
the footwear and therefore they do not wear appropriate footwear. Therefore a higher financial coverage
is needed from the Spanish National Health System, based on a higher knowledge of the footcare industry
and real data about the costs of orthopaedic shoes and insoles.
In addition, a recent study carried out in Spain, has concluded that the Spanish health system needs to
improve diabetic foot care by creating more diabetic foot units and improving the existing ones.
Specifically, this study concludes that some of the existing diabetic foot units do not include podiatrists,
which is crucial for effective management of the diabetic foot.
2.3.2 Overweight and obesity
In Spain, the prevalence of obesity is 23.2% of the Spanish adult population and 50.2% in people with
known diabetes. Obesity and overweight are the main causes in near 90% of patients with type 2 diabetes.
Thus, the increase in the prevalence of type 2 diabetes mellitus is related to the increase of obesity and
overweight as well as the prevalence of T2DM increases with the body mass index (BMI). This fact has been
demonstrated in the OBEDIA study as well as other studies from other countries. It seems that dyslipidemia
is the main risk factor in type 2 diabetes, followed by high blood pressure and physical inactivity. Therefore,
as aforementioned, Obesity and Diabetes are commonly coexisting diseases that pose a significant threat to
quality and length of life.
“A high percentage of diabetics do not wear suitable orthopaedic footwear or insoles, leading to a
high percentage of foot ulcers and amputations. A higher financial coverage of both, orthopaedic
footwear and insoles, by the Spanish National health system would be beneficial to face this
problem”
“For a good diabetes management, it is of high importance to create more diabetic foot units
comprised and coordinated by podiatrists. This measure would improve the diabetic foot care and
would reduce the high costs of its treatment”
“Obesity and overweight are the main causes in near 90% of diabetics. In Spain the prevalence of
adult obesity is of 23.2%, this figure reaches up to 50.2% of the diabetics”

The following graph shows the number of adults with overweight and obesity in Spain:
Figure 15: Overweight and Obesity by sex and age. National health survey (2011-2012).
Childhood obesity and overweight is of special interest for Governments, due to the alarming rates of new
cases in the recent years in the developing countries as well as its long-term effects. It is evident that
children and adolescents who are obese are likely to be obese as adults and are therefore more at risk for
adult health problems such as heart disease, type 2 diabetes, stroke, several types of cancer, and
osteoarthritis. This pattern is global and evident in Spain. As evident in the graph, the number of teenagers
and children who are obese and overweight in 2011-12 was 651.3 and 1,032.6 thousands respectively, what
gives an idea of the seriousness of this problem in Spain.
Figure 16: Overweight and Obesity in teenagers and children. National health survey (2011-2012).
overweightandobese in Spain in teenagers
0,0
100,0
200,0
300,0
400,0
500,0
10-14 years 278,2 186,8 464,9
15-17 years 120,0 66,4 186,4
Male Female Total
OVERWEIGHT AND OBESE IN TEENAGERS (in thousands)*
overweightand obese in childhoodin Spain
0
200
400
600
800
2-4 years 179,7 146,9 326,5
5-9 years 345,3 360,8 706,1
Male Female Total
OVERWEIGHT AND OBESE IN CHILDHOOD (in thousands)*
Obesity by sex and age (in thousands)
0
500
1000
1500
2000
2500
3000
MEN 462 631,70 1336,2 435,3 232,9 37,6
WOMEN 376,3 444 1045,6 499,8 354,9 66,4
TOTAL 838,2 1075,7 2381,8 935,20 587,80 104,00
18-34 35-44 45-64 65-74 75-84 over 85
Overweight by sex and age (in thousands)
0
1000
2000
3000
4000
5000
MEN 1640,4 1895,8 2751 889,7 576,8 104,7
WOMEN 797 860,8 1840,3 736,5 495,7 158,7
TOTAL 2437,4 2756,6 4591,3 1626,1 1072,5 263,4
18-34 35-44 45-64 65-74 75-84 over 85

The Ministry of Health is encouraging the NAOS Strategy (Strategy for Nutrition, Physical Activity, and
Obesity Prevention) to reduce obesity. In 2011 Spain had implemented a law requiring all schools to serve
healthy foods and banned unhealthy ones from the premises in an attempt to tackle this issue in children.
2.3.3 Elderly
A Spanish randomized study carried out with 1,277 people aged 65 years and
over concluded that the prevalence of diabetes increased progressively from
10.3% to 16.1% after 6 years of follow-up (1993 - 1999), with an incidence of 2.66
cases per 100 persons. Another similar Spanish study shown a prevalence of
16.8%. These data is consistent with other population studies carried out in other
developed countries.
It is crucial to develop new and better multidisciplinary health care approach to
improve old people’s quality of life, achieve a better diabetes - and obesity -
management and, as a consequence of carrying out these measures, to minimize
the high costs of diabetes and obesity treatment on public health.
2.3.4 The orthopaedic footwear sector in Spain
Each autonomous community of Spain covers different percentages of the total cost of a pair of diabetic or
customized shoes, and the insoles are in general not covered. This means that a Spanish citizen have to pay
more or less money for a pair of orthopaedic shoes depending on the community he/she lives.
Unfortunately, this also happens with the quality of the diabetic foot care received, as the diabetic foot
units in Spain are comprised by different specialties and have different population coverage and not all
autonomous communities have a diabetic plan.
Within the Valencian health system the estimated cost or a pair of bespoke shoes is 379.47 euro. The
orthopaedic manufacturer receives 137.39 euro from the health system and the patient 206.08 euro. The
estimated production cost is over 140 euro (depending on each case) and therefore the orthopaedic shops
have to increase the price of sale to the public to around 600 euro. Therefore the user pays around 400
euro for the shoe, which is unaffordable for a high number of patients.
In the case of diabetic foot, arthritic feet, neuropathic foot, and post-foot surgery, the Valencian
Community covers one pair of orthopaedic shoes every two years. Again, the patient must pay
approximately 60-80% of the cost, which in this case is estimated at over 60 euro.
As a consequence of the high price the patient has to pay, a high percentage of them do not wear correct
footwear. Therefore a higher financial coverage is needed from the Spanish National Health System, which
should have a higher knowledge of the real costs of orthopaedic shoes and insoles.
In addition, a recent study carried out in Spain, has concluded that the Spanish health system needs to
improve diabetic foot care by creating more diabetic foot units and improving the existing ones. This study
concludes that some of the existing diabetic foot units do not have podiatrists, what it is crucial for
effective management of the diabetic foot.

References
http://www.idf.org/sites/default/files/Atlas-poster-2014_EN.pdf
 Whiting, D.R., Guariguata, L., Weil, C., Shaw, J. IDF Diabetes Atlas: Global estimates of the
prevalence of diabetes for 2011 and 2030. IDF Diabetes Atlas: Global estimates of the prevalence of
diabetes for 2011 and 2030.
 (2008) European Commission. Directorate-General for Health & Consumers. Major and Chronic
Diseases. Report 2007.
http://ec.europa.eu/health/archive/ph_threats/non_com/docs/mcd_report_en.pdf
www.idf.org/diabetesatlas
 Soriguer F, Goday A, Bosch-Comas A, Bordiu´ E, Calle-Pascual A, Carmena R, et al. Prevalence of
diabetes mellitus and impaired glucose regulation in Spain: The Di@bet.es Study. Diabetologia.
2012;55:88–93.
 Smith BT., Lynch JW., Fox CS., Harper S., Abrahamowicz M., Almeida ND., et al. Lifecourse
socioeconomic position and type 2 diabetes mellitus: The Framingham Offspring Study. Am J
Epidemiol. 2011;173:438–47.
 Rubio, J.A., Aragón-Sánchez, J., Jiménez, S., Guadalix, G., Albarracín, A., Salido, C., Sanz-Moreno, J.,
(...), Álvarez, J. Reducing major lower extremity amputations after the introduction of a
multidisciplinary team for the diabetic foot (2014) International Journal of Lower Extremity
Wounds, 13 (1), pp. 22-26.
 Moss SE, Klein R, Klein BE. The prevalence and incidence of lower extremity amputation in a
diabetic population. Arch Intern Med. 1992; 152: 610-616.
 Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, et al. The global burden of diabetic foot disease.
Lancet 2005;366:1719–24.
 Almaraz MC, Gonzalex-Romero S, Bravo M, et al. Incidence of lower limb amputations in individuals
with and without diabetes mellitus in Andalusia (Spain) from 1998 to 2006. Diabetes Res Clin Pract
2012;95:399–405.
 Bakker K, Apelqvist J, Schaper NC. Practical guidelines on the management and prevention of the
diabetic foot 2011. DiabMetab Res Rev. 2012;28 Suppl 1:225-31.
 López-de-Andrés A, Martínez-Huedo MA, Carrasco-Garrido P,Hernández-Barrera V, Gil-de-Miguel A,
Jiménez-García R. Trends in lower-extremity amputations in people with and without diabetes in
Spain, 2001-2008. Diabetes Care. 2011; 34:1570-6.
 Rubio JA, Aragón-Sánchez J, Lázaro-Martínez JL, et al. Diabetic foot units in Spain: knowing the facts
using a questionnaire [published online November 4, 2013]. Endocrinol Nutr. oi:10.1016/j.endonu.
2013.07.002.
 National Health System of Spain, 2010 [Internet monograph]. Madrid: Ministry of Health and Social
Policy, Health Information Institute. Available at:
http://www.msps.es/en/organizacion/sns/libroSNS.htm
 Lopez-Bastida, J., Boronat, M., Moreno, J.O., Schurer, W. Costs, outcomes and challenges for
diabetes care in Spain. Globalization and Health. Volume 9, Issue 1, 1 May 2013, Article number 17.

 García-Armesto S, Abadía-Taira MB, Durán A, Hernández-Quevedo C, Bernal- Delgado E: Spain:
Health system review. Health Systems in Transition 2010, 12(4):1–295.
 Consumo MdSy: Estrategia en diabetes del Sistema Nacional de Salud. Madrid; 2007:85.
http://www.msps.es/organizacion/sns/planCalidadSNS/pdf/excelencia/cuidadospaliativos-
diabetes/DIABETES/estrategia_diabetes_sistema_nacional_salud.pdf
 Carlos Crespo, Max Brosa, Aitana Soria-Juan, Alfonso Lopez-Alba, Noemí López-Martínez y Bernat
Soria. Costes directos de la diabetes mellitus y de sus complicaciones en España (Estudio SECCAID).
Av Diabetol. 2013; 29(6):182---189.
 Catálogo De Artículos De Exoprótesis, Generalitat Valenciana – Conselleria de Sanitat
http://www.san.gva.es/documents/152919/157902/CATALOGO+EXOPROTESIS_14octubre2014.pdf
 Rubio, J.A., et al. Diabetic foot units in Spain: Knowing the facts using a questionnaire.
Endocrinologia y Nutricion. Volume 61, Issue 2, February 2014, Pages 79-86
 Data and statistics on Obesity - Health Topics WHO Europe. http://www.euro.who.int/en/what-we-
do/health-topics/noncommunicable-diseases/obesity/facts-and-figures
 Gomis, R. , Artola, S., Conthe, P., Vidal, J., Casamor, R., Font, B. Prevalence of type 2 diabetes
mellitus in overweight or obese patients outpatients in Spain. OBEDIA Study. Medicina Clinica
Volume 142, Issue 11, 6 June 2014, Pages 485-492.
 Calza S., Decarli A., Ferraroni M. Obesity and prevalence of chronic diseases in the 1999-2000 Italian
National Health Survey. BMC Public Health. 2008;8:140.
 Freedman DS, Khan LK, Dietz WH, Srinivasan SA, Berenson GS. Relationship of childhood obesity to
coronary heart disease risk factors in adulthood: the Bogalusa Heart Study. Pediatrics
2001;108:712–718.
 Agencia Española de Seguridad Alimentaria: Estrategia NAOS: estrategia para la nutrición, actividad
física y prevención de la obesidad. Madrid: Ministerio de Sanidad y Consumo; 2005.
http://www.naos.aesan.mspsi.es/
 Sánchez Martínez, M. , Blanco, A., Castell, M.V., Gutiérrez Misis, A., González Montalvo, J.I.d,
Zunzunegui, M.V., Otero, Á. Diabetes in older people: Prevalence, incidence and its association
with medium- and long-term mortality from all causes. Atencion Primaria. Volume 46, Issue 7,
August-September 2014, Pages 376-384
 Rosado Martín J., Martínez López MÁ., Mantilla Morató T., DujovneKohan I., Palau Cuevas FJ.,
Torres Jiménez R., et al. MAPA. Prevalence of diabetes in an adult population in the region of
Madrid (Spain). The Madrid Cardiovascular Risk study. Gac Sanit.2012; 26:243---50.21.
 Lipscombe LL, Hux JE. Trends in diabetes prevalence, incidence, and mortality in Ontario Canada
1995--2005: a population-based study. Lancet. 2007;369:750---6.18.
 Tromp AM, Pluijm SMF, Smit JH, et al. Fall-risk screening test: a prospective study on predictors for
falls in community-dwelling elderly. J Clin Epidemiol 2001;54(8):837–844.

2.4 Tunisia
2.4.1 Diabetes
According to the latest WHO report (World Health Organization), entitled "World Health Statistics 2013",
15% of Tunisians are diabetics (or 1.7 million people). Despite the efforts of health professionals, the
number of people with diabetes has increased dramatically in the last thirty years: 3.8% in 1976, diabetics,
9.9 % in 1997 and 15% in 2013.
WHO estimates that the management of diabetes in Tunisia is not optimal and that 50% of people with
diabetes are undiagnosed. Also, according to this organization, diabetes is among the top five causes of
death in Tunisia, and is the cause of 8.1% of deaths in women and 5.7% in men.
Figure 17: Prevalence of diabetes in Tunisia.. Source: WHO report (World Health
Organization), "World Health Statistics"
According to the last statistics of project TAHINA in 2008, the prevalence of obesity in adults (> 20 years) is
27.26%. This prevalence is higher in urban than in rural areas (31.6% vs. 18.13%) and women are twice as
affected by obesity than men (38.16% vs. 15.97%).
According to the same survey, overweight affects 35.82% of Tunisian adults, more men (36.98%) than
women (34.69%). More adults living in cities are overweight than those living in rural areas.
“The management of diabetes in Tunisia is not optimal. It is estimated that 50% of people with
diabetes are undiagnosed”

Figure 18: THAHINA project results, of overweight and obese
According to the National Institute of Nutrition and Food Technology (INNTA), one in four adolescents, aged
15 to 19, is suffering from overweight or obesity. The prevalence is similar in both sexes.
Figure 19: Data of overweigh and obesity among teenagers, from National
Institute of Nutrition and Food Technology
33
35
32
30
31
32
33
34
35
36
Capital Center South-East
%
Prevalenceofoverweight
among adults
39
31 30
0
10
20
30
40
50
Capital Center South-East
%
Prevalenceofobesity among
adults
12
4
0
5
10
15
Overweight Obese
%
Prevalence of overweight and obesity
among teenagers
One in four adolescents, aged 15 to 19, is suffering from overweight or obesity in Tunisia.
The prevalence is similar in both sexes.

Figure 20: Overweight and Obesity for children in Tunisia.. Source: web site of INNTA
2.4.3 Elderly
According to the National Institute of Statistics (INS), 2011, 10.1% of Tunisians are aged 60 years of age and
over. This percentage has increased over the last 20 years from 6.6% in the 80s and is steadily increasing
each year.
Figure 21: Distribution of population by age in Tunisia.. Source: web site of INS.

By 2039, it is anticipated that for the first time in the history of the Tunisian population, the proportion of
people aged 60 years of age and over will be higher than for children under 15 years of age: 20.1% versus
19.3%.
Age / year 2019 (%) 2024 (%) 2029 (%) 2034 (%) 2039 (%)
0 - 4 years 7.6 6.8 6.0 6.4 6.4
5 - 14 years 14.9 14.6 13.7 13.9 12.9
15 - 59 years 64.5 63.4 62.6 61.5 60.6
60 years + 13.0 15.2 17.7 18.2 20.1
Table 3: Estimation of Population structure by age (%). Source: Pr.Hajem et Saidi (INSP).
2.4.4 The orthopaedic footwear sector in Tunisia
In Tunisia there are three categories of footcare actors:
1. Doctors: Physical physicians, Orthopedists, rheumatologists, dermatologists, diabetologists, orthopedic
surgeons
2. Health professionals: some podiatrists trained in Europe (public training license in podiatry was created
for 3 years in Sousse), orthopedists, some specialized physiotherapists, occupational therapists
3. Manufacturers or retailer of orthopedic footwear: the main actor in custom shoe manufacturing in
Tunisia is the “Centre d’appareillage Orthopédique CAO”. This is a public institution under the National
Social Security Fund that manufactures footwear, orthotics and other types of equipment as prescribed
by the specialist.
There are also private centers specializing in the manufacture of custom shoes (about ten in total) and
“commercial”. Orthopedic shoes are also available at equipment retailers.
Different types of orthopedic shoes are supported by the CNAM (National Health Insurance Fund, national social
service also supporting and reimbursing the shoes) or by private insurance mutual.
The patient with a supported CNAM or private insurance can attend the "Centre d’appareillage Orthopédique
CAO" for provision of his shoe. The price of the shoe in the center is the one approved by the CNAM, the quality
of shoe is very good but the waiting times are very long. The patient may also move towards centers of private
orthopedic devices, the prices are higher than those approved by the CNAM, quality is acceptable and delivery
times are short.
For people with lower incomes, "CAO orthopedic center" supports the manufacturing of orthopedic shoes.
According to Dr. Fethi Sraïri, director of the “Centre d’appareillage Orthopédique CAO”, between the years 2007
and 2010, the center was making 500 to 600 pairs of shoes a year. The delivery time varied from 2 weeks to 3
months. The cost of this type of shoes is between 150-300 Dinars.

How orthopedists communicate the requirements to the shoe producers and who adapt the shoes for
the specific needs of the patient.
Doctors (Physical and rehabilitation physicians, orthopedists, rheumatologists, dermatologists, diabetologists,
orthopaedic surgeons) prescribe to the patient the type of equipment needed (orthotics, custom made
orthopaedic shoe/commercial therapeutic shoe/shoes, insoles....) and communicate this requirement to
orthopaedists. The best way is to discuss during a specialized multidisciplinary consultation, where the technical
specifications of the shoe or the sole can be defined according to the patient's needs and socioeconomic
conditions.
Orthopaedic shoes manufacturing
In Tunisia there are 3 classes of orthopaedic shoes:
 Custom-made orthopaedic (personalized) shoes (molding the shape of the foot) manufactured in the
"Centre d’appareillage Orthopédique CAO” or by private orthopaedists.
 Orthopaedic shoes imported, in which the orthopaedists incorporates insoles tailored to patient needs
 Therapeutic shoes sold in shoe stores (imported: about 250-300 DT pair)
So there are no orthopaedic shoes producers specialized in these shoes, but this type of shoes are made by
orthopaedists or imported from Germany, Turkey or France. In general, for the production of orthopaedic
shoes it's better if there is a specific certification (from orthopaedist, podiatrist etc.). Regarding the
reimbursement, it is received by the orthopaedic technician.
References
 World Health Organization, Statistiques Sanitaires Mondiales 2013,
 Habiba Ben Romdhane (2006), project TAHINA (Transition Epidemiological and Health Impact
NorthAfrica), enquête nationale morbidité et recours aux soins.
 National Institute of Nutrition and Food Technology (INNTA), http://www.institutdenutrition.rns.tn/
 Pr. Ali Smida et coll (2008), Etats de santé des tunisiens en 2030, Université Virtuelle de Tunis.
 Dr Nadia Ben Mansour, Dr Said Hajem, Transition Démographique en Tunisie: Déterminants et
impacts, Institut National de la Santé Publique.

2.5 United Kingdom
2.5.1 Diabetes
The prevalence of diabetes within the UK is around 4% of the population, with 90% of these cases being
Type 2 diabetes, however, in addition, it is estimated that a further 630,000 cases are undiagnosed. An
estimated expenditure of approximately £3000 per person with diabetes is undertaken, costing the
National Health Service £10 billion per year. Approximately 21,406 deaths of 20-79 year olds are related to
diabetes per year and it is the leading cause of limb amputation in the UK. The distribution of diabetes
within British society is higher within some ethnic groups, for example it is at least twice as common in
people of South Asian and African Caribbean descent within the same region. Additionally, occurrence of
Diabetes and morbidity from complications associated with diabetes are higher amongst the poorest
people in the UK compared to the richest.
Diabetes UK is a national charity within the UK, who “care for, connect with and campaign alongside and on
behalf of all people affected by and at risk of diabetes.” They raise funds, sponsor scientific research,
campaign to influence government strategy and network healthcare professionals who work in care for
adults with diabetes. Diabetes makes the patient applicable for National Health Service funded podiatry
appointments and patients with clinical need are entitled to two pairs of shoes via the National Health
Service. The average cost for a patient to replace damage or lost pairs is over £300. Standard wide fit and
stretch upper footwear is available through online retailers for £70 and upwards.
One quarter of the UK adult population is overweight or obese (men 24%, women 25%), and 42% of men
and 32% of women are overweight. Obesity is the second-largest “human-generated” impact on the UK
economy, behind smoking, costing £47 billion annually. As an individual’s weight increases and their BMI
band increments from normal to overweight there is a 31% increase in their medical costs in the UK (from
overweight to obese this increases to 58%), however their total cost is less due to healthy weight individual
requiring more end of life care.
Various UK charities or organizations exists in the UK to campaign for obesity and. For example, The British
Obesity Society campaigns and represents the interests of people living with, or working in the field of
obesity. Additionally, the National Obesity Forum raises awareness of obesity in the UK and promotes ways
in which it can be addressed such as public-facing initiatives and the training of clinicians and healthcare
professionals. Additionally, the NHS has identified this as a key area for national actions for 2015-2020
(NHS, 2014); strategies focus on diet and activity.
“The proportion of adults with diabetes in the UK is 4% of the population”
“The proportion of adults who are obese in the UK is 25%, with over 35% overweight”

Specific footwear for larger fit is available for adults who are obese including specialist online retailers and
some high-street footwear retailers stock footwear with additional width fitting (with a wider sole in
addition to a wider upper) for £70 and upwards for leather work shoes. If the adult is otherwise healthy
(and the footwear dimensions are large enough and the material suitable within retail footwear) there may
be no requirement for specific footwear through the health service for obese and overweight individuals.
2.5.3 Elderly
The population of the UK aged 65 and over was 11.1 million (17.4% of the UK population) in 2013 and is
steadily increasing each year. By 2050 one quarter of the UK population will be 65 years or over, reducing
the ratio of people of working age to pensionable age to less than 3. Sixty five percent of Department for
Work and Pensions benefit expenditure goes to those of retirement age. Increasing numbers of elderly
adults also impacts on the budget of the NHS and average spend per annum for retired households (£5200
in 2007-2008) is nearly double the equivalent for non-retired households. However, this figure groups all
age groups who are retired; it is estimated that the average cost of providing health services for a person
aged 85 years or above is three times that for an adult aged 65 to 74 years. Life expectancy varies across
the UK with the richest parts of the country exceeding the poorest by an average of 17 years.
NHS footcare for the elderly is based on need, with low-risk patients requiring to seek private treatment or
self-manage. Approximately 16% of older people in the UK received NHS treatment in 2002-2003. Footwear
advice for older people is widely available in the UK (although of varying quality) from charities such as Age
UK in addition to the College of Podiatrists and the NHS. Footwear aimed toward the elderly customer is
also available via mail order, through mobility retailers, on the high-street and online at a wide range of
prices (with varying actual suitability).
2.5.4 The orthopaedic footwear sector in Uk
Orthotists, Podiatrists and orthotic technicians within the UK represent the “shoemakers” of the clinical
route for patients to be prescribed footwear. Physiotherapists, Orthotists and Podiatrists may also be
providing or modifying insoles or orthotics for patients. Via the National Health Service (NHS) there are no
specific clinical guidelines to define which patients and with what severity should have therapeutic
footwear. However, National Institute for Health and Care Excellence (NICE) guidelines recommend
footcare services should be available for long-term conditions such as Diabetes. The prescription of off the
shelf, modular or personalized footwear/orthotics is therefore reliant on a combination of clinical decisions
(based on patient need) and cost. The footwear providers are selected by individual NHS trusts and
therefore vary by region and the availability of assessment equipment and footwear provision varies greatly
based on regional budget. Some services do not have the capacity to produce orthotics or footwear
internally and therefore, if the patient receives a prescription for footwear from a medical consultant this
shall be taken to a commercial orthotist to make the shoe. This may be limited in terms of appointment
time and user involvement and feedback.
“By 2050 25% of the UK population will be 65 years of age or older”

As an alternative to the National Health Service, orthopaedic footwear/orthotics can also be purchased
from (or adapted by) podiatrists and orthotists who operate private practices. Additionally specialist
shoemakers may also offer this service; they not have any clinical qualifications, however use their
experience to produce footwear to meet user-specific needs with handmade processes to produce
customized footwear. Others may be Healthcare Professional Council registered Orthotists.
Such shoemakers may advertise to patients with plantar fasciitis, bunions and more extreme conditions and
provide assessments at home or in clinics using plantar pressure plates for example. Footwear shall be
provided within approximately one week to one month depending on the level of customization. Such
companies shall be registered with voluntary organizations such as the Healthy Footwear Guide or the
Society of Shoefitters, but no registration with a governing body is compulsory to operate.
In the UK medical devices (which orthotics/footwear that claim to provide benefit are) must be CE marked
and supported by evidence that they perform as intended for the specific patient for which they are
designed. This is obviously not the case for all individual customized shoes, however should be the case for
orthotics and footwear available “off the shelf” or modular items. These items may also be available in
retail such as high-street pharmacy chains. Additionally, within the retail setting there are footwear
providers that offer footwear design to accommodate specific user needs e.g. the diabetic foot, which is
generally available online or in specialist stores. These shoes may incorporate specific design features, last
shapes or materials deemed more suitable for wearers and therefore sit between prescription/customized
footwear and standard high-street retail footwear.
References
 Age UK (2005) Best Foot Forward: Older People and foot care.
 Cracknell, R. (2010). The ageing population, Key Issues for the New Parliament 2010. House of
Commons Library Research.
 Diabetes UK (2014) Diabetes: Facts and Stats.
 Hex, N., et al.(2012) Estimating the current and future costs of Type 1 and Type 2 diabetes in the
United Kingdom, including direct health costs and indirect societal and productivity costs. Diabetic
Medicine. 29 (7) 855–862.
 HSCIC: Health and Social Care Information Centre (2012) Statistics on Obesity, Physical Activity and
Diet (England).
 IDF Diabetes Atlas, 2014
 McKinsey Global Institute (2014) Overcoming Obesity: An initial economic analysis.
 National Health Service England (2013) The NHS belongs to the people: a call to action.
 National Health Service England (2014) The NHS Five year Forward View.
 Office for National Statistics (2014) Annual Mid-year Population Estimates, 2013.
 Pennine Acute Hospitals NHS Trust (2013) Footwear for Diabetic Patients.
 SABRE, 2012, Southall and Brent Revisited. Diabetes & Heart Disease Research Study,
http://www.sabrestudy.org/?cat=12

3 Methodology
The strategic research agenda (SRA) started with the information gained from the SoA analysis and the
information about patients’ needs. Both documents were the starting point of the SoHealthy project and
the main working document for the members of the working groups. The following step was to prioritise
the technology areas in order to know the timeframes for their influence and arrange them in the short,
medium and long term. This task was carried out by the SoHealthy experts’ community through the “state
of the art” validation forms as well as the different events carried out throughout the project (such as the
network event held in Manchester and two validation workshops held in Spain and Tunisia). The results
about the prioritised technology areas were also validated by the working group members during the
development of the strategic research agenda. After prioritising the technology trends, the working groups
identified the main footcare sector’s challenges and opportunities, key research and innovation priorities,
industry innovations and key enablers, following the work plan and steps contained in an action plan
developed for that purpose and that can be consulted in the following pages of this document.
The following figure outlines the rationale followed for the development of the SRA:
Figure 22: Rationale for the SRA development
Thereby, the process to define the Strategic Research Agenda included numerous sub-phases utilising
information previously gained from the project. As aforementioned, such sub-phases and steps were
explained in detailed in an action plan that was developed as first step towards the development of the SRA

and that had the objective of ensuring an efficient, detailed and realistic planning of the necessary activities
for completing the SRA.
The following figure shows the different sources of information that have fed the working groups for the
development of the SRA:
Figure 23. Schematic for the methodology to define the working groups
The main documents and tasks related to the SRA are explained below:
3.1 State of the Art Document
The state of the art document (State of the art of the most relevant technology areas related to the
footcare sector, March 2014) identified an array of research and technology areas which are relevant to the
footcare and footwear sector. It defined these areas and addressed their relevance to directly impact on
patient needs within the scope of the SoHealthy project. This documented acted to define the technology
areas of particular relevance and impact to the outcomes of SoHealthy project and therefore focus the
research groups to these areas.
3.2 Partner Expertise Document
The partner expertise document defined the resources and competencies available to each of the
SoHealthy partners. This systematically identified the technology and research areas identified as relevant
to the footcare and footwear sector and identified the resources available to each partner and therefore to
the project with these focus.

3.3 Other Tasks
Additional tasks were undertaken within the project to establish the state of the art and relevant
stakeholders’ personal research priorities. Two of these include a state of the art task at the networking
event and two validation workshops held in Spain and Tunisia.
Network Event
A task included in the network event (held on February 2014) encouraged delegates to comment on
relevant technology and research areas to the SoHealthy project. The nature of these comments identified
what the delegates (as stakeholders in the footwear and footcare sector) see as research and technology
areas of priority. Additionally, what they identify as limitations or barriers to their roles were also
established; another aspect which acts to identify technology areas of interest or priority to negate these
barriers or reduce these limitations.
Spanish Workshop
The Spanish “Technology analysis and assessment workshop” (held on January 2014) included a group of
influential Spanish podiatrists. The attendees rated and prioritised their perceived areas of influence from
the original list of technology areas. They were asked to focus on both patient needs and technology
priorities. The podiatrists also added to the technology areas originally established for the state of the art
document, which validated the scope of the project.
Tunisian Workshop
On June, 2014, a workshop was organised in Institut National d'Orthopédie Mohamed Kassab (Tunisia) with
30 Podiatrists and healthcare professionals of different specialties related to foot health to collect input
relating to the current state of the art and technology relevance to patients and future research priorities.
Specifically, the attendees were asked to prioritise and rank the technology trends, mainly those from the
technology areas related to the clinic side (i.e. biomechanics, microbiology, etc.).
3.4 SOA Validation from Expert Community
The questionnaire and state of the art document were sent to industrial, research and clinical experts who
acted to validate the information collated in the state of the art document. The representative experts
were selected from the SOH expert community to complete the questionnaire and highlight their research
priorities through data representing their perceived relevance of technologies and the timeframes over
which they considered these to be relevant.
3.5 Working Groups
Following the synthesis of work done in several steps five working groups were created. Namely, that each
group could demonstrate it aims to meet user needs, that the expertise of the project partners were
sufficient to fulfil the aim of the working group within the scope of the SoHealthy project and that there
existed a relatively even distribution of technology areas across groups i.e. that potential volumes and
scopes of information and influence were similar between groups.

The action plan for the development of the SRA contained relevant information about the working groups’
management (committee structure definition, the criteria selection of the working groups’ members,
definition and setup of a work plan, definition of roles and responsibilities, definition of a communication
management plan, etc.) as well as the focus and objectives of the SRA.
Figure 24. Committee structure
WG1: Towards more efficient provision
Problem definition
Provision of footwear can be too slow, too iterative, is
rarely “right first time” and is therefore expensive.
Aim
To improve and develop efficient (for both time and
cost) design and manufacturing processes for the
provision of footcare and footwear products to the
consumers and wearers defined in the SoHealthy
project.

WG2: Towards reduced foot infection
Problem definition
Foot infections are common and problematic in skin
and nails. Footwear factors (e.g. temperature,
humidity, mechanical irritation, chemicals) are
strongly associated with favourable microbial
growth and therefore can increase the risk of foot
infections.
Main objective
To help reduce infection and hygiene issues in the
SoHealthy project populations through the
advancement of microbiology, nano/micro-
encapsulation and adhesives for inclusion in
footwear and footcare products.
WG3: Towards material innovations
Problem definition
Footwear materials are passive in the main and
can offer a limited range of functionality.
Footwear technologies need to be more
sustainable in the long term. To offer more
effective solutions and therefore be competitive,
the footwear sector should seek to adopt
materials innovations from allied sectors.
Main objective
To provide suitable materials for use within end-
user products in addition to within research and
development in the footcare and footwear
sector.

WG4: Up-skill providers
Problem definition
Emerging technologies and new practices could both
lead to improved efficiencies for providers and
solutions for end users. However, providers
(clinicians, industry and research sectors) require
constant updating in their fields and in the fields
immediately allied to their work (e.g. clinical
knowledge for industry).
Main objective
Training and education for stakeholders to improve
efficiency and processes throughout the provision
process including manufacturers, designers,
clinicians, retailers and brands.
WG5: End-user driven
Problem definition
The foot health, foot and needs of the three end user groups targeted by
SoHealthy have not yet been fully characterised. End users and their
needs are not consistently embedded in the decision processes and
innovations within the patient/consumer journey. The education of end
users is not co-ordinated such that they feel empowered in managing
their patient journey leading to positive influences on their health
behaviour. A more end user driven journey would lead to more
appropriate and effective product solutions and greater provider
competitiveness.
Main objective
to define end user (wearer) needs and characteristics and embed these
in all subsequent processes, establish the efficacy of existing or new
technologies/products in user terms, and educate users and patients in
the availability and expected value of devices and treatments.
Figure 25. Summary of the working groups’ objectives and problem definition
One of the main criteria selection of the working group members was that the working groups had to be
multidisciplinary in order to cover all research areas involved in each WG and from different European and
Mediterranean countries so that to ensure a balanced representation of skills and qualities and a broad and
deep range of expertise and perspectives. In addition, the chairs tried, when possible, to involve
representatives from different sectors (industry, academia, health care, etc.). It was agreed that each WG
would not exceed 10 members in order to efficiently manage each one.

Each working group worked independently in the field of interest, but proceeded parallel to the others and
considered cross-linking.
Several operational steps have been defined, in which the results of each one constituted the basis for the
next one.
The diagram below describes the various steps followed by each working group:
Figure 26. Main steps of each working group
The first step was to map the patient journey, which it was the common framework for all working groups.
These journeys follow the patient through a healthcare or retail route for the provision of their footwear to
treat or aid their foot health problem. Patients’ needs are - should be - the drivers of the footcare sector,
leading research topics towards new industry applications and these ones to new products and/or product
modifications. For each phase, the experts had to indicate what stages of the patient journey their working
group impacted on.
Starting from the relevant stages of the patient journey identified in the previous step, in this step the aim
was to define the Challenges and Opportunities for each of them. These challenges and opportunities had
to determine the desired impact of the research and innovation priorities mentioned. Furthermore, the
experts were asked to specify if these challenges are different in the case of diabetic, aging and obese foot,
which are the main target groups of the project. Challenges and opportunities originated from a mix
between the different research fields, the needs of industries and companies, and especially the needs of
patients/users.
Starting from the 90 technology areas identified in the State of the art report, developed at the beginning of
the project, each working group chair created a list with the technology trends directly connected to its

working group. Then, experts/partners were asked to rank the first 5 technology/research trends in order
of importance and, if necessary, add new trends which they felt were essential. Furthermore, they had to
explain the reasons why they chose those technology trends and justify their importance for the influence
of the working group.
After choosing the most important priorities, it was decided to link the research priorities to the challenges
and opportunities identified in the previous step and, also, to describe the possible related innovations or
developments.
The main actors in each research priority e.g. key organisations in the field of research, academia, policy,
etc. were defined during a working group seminar held in Barcelona (February 2015), where the members
had the opportunity to sign-off the document relating to the individual working group priorities and discuss
with the other members any issues or doubts that had arisen during their input to the working groups
activity.
During that seminar, the working group chairs presented 1-2 project ideas relating to the outcomes of their
working group, relating to the research priorities obtained from the previous step. The project ideas
included research priorities related to other working groups, not only to that of belonging, as some
priorities are strongly linked to other working groups’ priorities. The project ideas were presented to the
members, who were asked to evaluate them according to the established appraisal criteria.

4 Impact through a user oriented research
The patient journey (Figure 27) was developed to provide a framework for all working groups to align their
aims to impact upon the processes of patient/consumer journey. This therefore formed a common “Action
Plan” for all working groups to shape their input into the development of a Strategic Research Agenda. The
Patient journey follows the patient through a healthcare or retail route for the provision of their footwear
to treat or aide their foot health problem.
In defining the working groups, the Patient Journey enabled a thorough evaluation and validation of the
working groups to ensure they were distributed evenly across the technology areas, were sufficiently
defined to accommodate partner expertise and all impacted on the patient journey through the footcare
and footwear sector. Later this process map provided structure for the working groups to ensure that their
research impacted on the patient/consumer journey.
The first stage of implementing this process was to map the related technology areas from the working
group onto the journey, by highlighting the stages (with justification) that the working group and related
technology area impacts on the journey. Once each working group had “mapped” related technology areas
and potential contribution onto the Patient/Consumer journey the apparent cohesion and unified aim of
the individual groups was clear. The Patient Journey also ensured that all following outcomes from the
working group could be related back to the provision of footwear (or footcare) and therefore the ultimate
aims of the SoHealthy project. Later in the working group tasks this approach also highlighted overlapping
technology areas and working groups to highlight areas where synchronising research and sharing
resources will benefit the overall value chain in the future implementation of the SRA and for consideration
in the subsequent section relating to Cross-cutting issues.

Figure 27. Patient Journey

5 Research and innovation strategies
5.1 Towards more efficient provision
The manufacturing of suitable and fit for purpose footwear is essential for specific populations.
Comfortable and well-fitting footwear is of great importance to prevent, improve and/or alleviate injuries,
foot ulcers, oedemas, toe deformities, as well as falls and tripping and many other feet problems and
pathologies that people who have diabetes, are obese and older may experience. Thereby footwear can be
designed and be made of materials that improve balance, flexibility and stability, increase proprioception,
slip-resistance and/or grip, demand less energy and muscular effort to walk, reduce dorsal and plantar
pressures, and many other functionalities related to footwear. The complete list of footwear /footwear
components’ requirements as well as information about the foot problems that can be prevented,
alleviated and/or improved by wearing suitable shoes, in each of these groups, can be consulted in the
State of the Art analysis carried out at the beginning of the SoHealthy project.
Therefore, footwear and its components are an important tool of work, not only for the industry, but also
for clinicians and health professionals. However, the current process of producing customised orthopaedic
footwear may not produce footwear that is right first time and therefore delays. In addition, this industry is
characterised by a high handmade component, as the number of technologies that have been implemented
in this industry is very low compared to other industries, even compared to the wider footwear industry.
Only in recent years has the orthopaedic footwear sector implemented technologies, mostly from the wider
footwear sector. One of the main drawbacks of an industry characterized by a high degree of hand work is
that customised orthopaedic shoes/insoles are much more expensive than a pair of conventional
shoes/insoles, which influences, in many cases, the purchase intention of some patients that cannot afford
them or think the product is too expensive. Thus this working group was created around this problem, in
the framework of the SoHealthy project,, with the aim of identifying the most relevant research priorities
that lead to a better, cheaper and faster provision of footwear.

5.1.1 Challenges
The key challenges identified relating to a more efficient provision of customised orthopaedic
footwear/footcare components for the healthcare route of the patient journey are as follows:
1. To develop new training courses for both clinicians and manufacturers
This challenge relates to the link between the clinic and industrial sectors and the need for training relating
to new technology developments such as new CAD/CAM tools, new or improved manufacturing processes,
etc. Many times, despite being strongly linked, health care professionals do not understand the details of
the foot care industry and vice versa. For example, in the case of CAD/CAM, the culture within clinic needs
to change to make CAD-CAM tools and technologies favourable when compared to existing methods. This
involves both up-skilling/training as well as changing attitudes and will take time to change. Specific
curricular content should be created for podiatry schools and practitioners to bring technology to real life,
outside of specific manufacturing labs. In this sense, specific actions at podiatry schools on advanced
technologies will help to incorporate them within the podiatrists routine.
It would be also beneficial that the orthopaedic shoe/insole manufacturers acquire minimum knowledge
about foot morphology as well as an understanding of the reasons why the clinician configures the product
in a given way. From the other perspective, the clinician should also know how the clinic prescription turns
into a production order, as this mutual understanding would help the design and manufacture better
products.
From this challenge comes the opportunity of creating an expert network to support clinicians in the day to
day use of the new technologies in addition to training from the software and hardware provider.
2. To reduce misunderstandings between the different stakeholders and to assure minimum quality
levels at each step of the supply chain
Electronic orders should replace manual orders in order to reduce misunderstandings between the
different stakeholders of the footcare sector’s value chain. The order or prescription has to be clear for
both the patient and the manufacturer, and it has to include a figure (render) of the product that the
clinician has prescribed. This is to avoid mistakes during the shipment and/or manufacturing. In addition,
the patient should receive a printed and/or electronic copy of the order. In this sense, the development of a
Web portal where the patient can check the status of the orders would offer a good opportunity for
advancement. This way the patient is involved in the order process and he/she is better informed,
increasing their satisfaction with the product and service, and achieving higher patients' adherence to the
treatment.
Nowadays there is no common model of clinic prescription or other processes within the footcare sector’s
value chain. In this sense, the definition of a data model would allow for the exchange of information
between the clinician and the manufacturer at any point of the value chain (prescription, design,
production, delivery, etc.) and therefore it would be a great advance for the sector. This advance is related
to the standardisation of the information and/or processes and it would enable a better flow of the
information and materials throughout the value chain as well as reducing the mistakes produced within the
different processes of the value chain.

3. To reduce the number of fitting tests by getting greater accuracy, speed in design and cost
effectiveness in the specification/design phase
Within the process of manufacturing customised orthopaedic footwear it is normal to carry out several
fitting tests before obtaining a final model, this is one of the main causes of delay in the provision of
customised orthopaedic footwear. This is mainly caused because there are limitations in translating the
patient’s foot measurements into a last to produce the shoe. The last, a solid 3D object, is the
representation of the foot, which is a flexible structure. In addition, the inclusion of other elements, such as
orthoses, orthopaedic insoles made of different materials, etc., makes this process more difficult, as the
clinician cannot assess the effectiveness of these elements until these ones are tried on by the patient to
check for proper fit. Therefore, the development of IT tools that include information about the real
behaviour of material deformations and foot parts would be a great advance within the footcare sector as it
would enable the clinician to predict the result before manufacturing the product, reducing time and costs.
Related to this, the development of devices or materials embedded with
sensors aimed at collecting data in dynamic conditions would provide more
accurate data about the behaviour of the patient’s foot, leading to a more
realistic design and more effective treatment. Additionally, there are many
other technologies that can speed up the specification/design process and
that can be consulted in the description of this working group’s research
priorities.
4. To get a greater accuracy, speed in design and cost effectiveness in the last design and
manufacturing phase
The design of good lasts is a masterpiece of engineering and a work of art
on which the fitness, quality and appearance of the finished shoe
depends. In addition, as said before, the fit of a shoe depends greatly on
the shoe last and therefore this is the most important construction
element of a shoe, especially for manufacturing customised footwear.
According to the fitting test results, the last is modified several times to
the required shape and measurements until the final version is achieved.
This time-consuming work that delays the delivery of the shoe and
therefore one of the main sector’s challenges is to speed up this process.
This goal can be achieved with the development and use of new
production technologies, based on 3D printing (use of Additive
Manufacture technologies).

5. To improve fitting and patients’ comfort perception
The fit of a shoe is especially important in the case of diabetic, obese and the older foot, because the
altered shape may not be adequately catered for by conventional footwear, so people affected from
diabetes, obesity and older people generally suffer from footwear-related discomfort. This is a complex
issue because how the foot shape changes with each disease is patient-specific. As a result, existing
algorithms for adapting last geometry, insole geometry and selecting the associated materials do not satisfy
the specific requirements of these target groups. Consequently, new algorithms and methodologies are
required to inform the geometries of the footwear and insoles for population or patient specific footwear.
The geometries affect the materials that have to be selected, and so too will the altered foot tissue
properties that are known to occur in both obesity and diabetes (e.g. muscle wasting, thinner stiffer fat
pads on plantar surface, greater fat deposits on dorsum). This challenge is also related to other interesting
opportunities for the sector such as the development of new CAD tools that can be consulted within the
third research priority.
6. To collect and integrate data about patients’ feet and the biomechanical behaviour of
footwear/footwear components for the clinical assessment of footwear/ footwear components
Thanks to 3D digitisers, the clinicians get relevant foot
data measurements, these data are normally included
in the order, but it is still necessary to include
information about the activity, weight, pressure, gait
and the type of skin for a right prescription. Therefore,
it is important to further progress the knowledge
about the behaviour of the foot inside a shoe, with
data from plantar and dorsal sides. This advancement
should be linked to the development of suitable
software tools able to process and integrate all data.
Such software tool should include the materials
properties and population specific recommendations,
as well as simulation tools in order to advise the clinician. This simulation tool should be integrated in a
homogeneous framework in order to be able to simulate the whole shoe behaviour, as a previous step to
order it. This would make possible to manufacture a shoe with the right design and materials.
Related to this challenge, the development of user-oriented simulation systems for product-service
modelling are needed in order to simulate biomechanical behaviour of materials, components and
footwear, thus supporting the shoe and orthoses designers suggesting them the product geometry and
materials to develop a curative/preventive personalised shoe. This implies to move from the traditional
design systems (with a high manual component) to innovative ones, based on CAD technologies. These
innovative design systems have also to be oriented to innovative manufacturing systems, based, for
instance, within the additive manufacturing technologies. However, despite Additive manufacturing
offering high-quality bespoke products quickly and efficiently, which can be highly personalised to
individuals; currently, the design of custom foot and ankle orthoses is heavily restricted by the materials
and methods used to manufacture them.

The key challenges identified relating to a more efficient provision of footwear/footcare components for
the retail route of the patient journey are as follows:
7. To collect data on user’s satisfaction and needs in the fastest and simplest way possible
To collect data on user’s satisfaction and needs is crucial to better understand the psychology of the
patients and their emotional response toward the product, which is strongly related to the patient’s
adherence to the treatment. In this sense, as aforementioned in challenge No.2, the development of a Web
portal, with links to social networks, where the patient can check the history and status of the orders would
be very useful. This way the patient is involved in the order process and there is a higher interaction with
him/her as the patient could give information through the Web portal about his/her experience in the use
of the product, so that both, the clinician and the manufacturer receive feedback from the product itself
(the orthopaedic footwear or footwear component). Within this challenge, it would be also an opportunity
to develop 3D virtual testers by means of augmented reality techniques as it is explained in the research
priority No.6.
8. To increase user’s satisfaction by improving fit, comfort and speed of product provision
This challenge is similar to challenge no.5, as fitting and comfort are crucial for both, the healthcare and
retail routes. Opportunities related to this challenge would be, for example, the use of additive
manufacturing (AM) to create new designs to provide a greater range of prescription options or to analyse
shoe components potential production with AM before their manufacturing. Also to integrate AM
techniques with CAD design software and musculoskeletal modelling software and / or to integrate robotic
systems for last pulling operations and mould release of footwear soles.

5.1.2 Research priorities
Research Priority
RP1.1
New 3D prescription tools for the prescription of orthopaedic
footwear/insoles based on biomechanical and material essay data
SHORT DESCRIPTION Clinical prescription is the first step of the designing and manufacturing
process of customised orthopaedic shoes/ insoles/orthotics, etc. The higher
quantity of information clinicians can process and manage from the patient,
the better the clinical prescription will be and therefore the treatment will
be more effective. Orthopaedic shoe/insole manufacturing depends not only
on the measures of the foot, but also on the information about the
behaviour of the materials, the biomechanical behaviour of foot, etc. In this
sense, a 3D prescription tool able to process information from different
sources, such us biomechanical and material essay data, would provide
valuable information to the clinician and it would reduce the fabrication
time as the final product would be based on more accurate data and the
number of trials needed would decrease.
A 3D prescription tool would avoid the use of different terminology for
orthoses/footwear types, modifications and product options, whichresults in
confusion for clinicians. Therefore, this prescription tool would make the
choices and decision-making systematic and auditable, and would enable
excellent clinical quality control opportunities.
RELATED INNOVATION - Specific software tools linking clinical prescription and CAD tools for the
design of insoles/soles/orthotics/last.
- Combination of the 3D prescription tool with data integration tools and
with other processes of the production process.
- Development of specific courses/training programs related to the use of
this software tool
CHALLENGES 2. To reduce misunderstandings between the different stakeholders and to
assure minimum quality levels at each step of the supply chain
3. To reduce the number of fitting tests by getting greater accuracy, speed in
design and cost effectiveness in the specification/design phase
4. To get a greater accuracy, speed in design and cost effectiveness in the
last design and manufacturing phase
6. To collect and integrate data about patients’ feet and the biomechanical
behaviour of footwear/footwear components for the clinical assessment of
footwear/footwear components to verify that it fulfils the desired
requirements.
PATIENT JOURNEY HEALTHCARE ROUTE:
- Clinic: healthcare professional decision, agreed design, fitting, clinical
assessment, data collection
- Manufacture: specification/design, make last.
KEY ENABLERS Hospitals, diabetic foot units, health care professionals; footwear technical
institutes, universities/research centres expert in biomechanics and
materials development, Ministries of Health.

Research Priority
RP1.2
Cheaper and portable 3D and 4D foot scanner
SHORT DESCRIPTION This priority refers to the democratization of technology, which is related
with the introduction of the innovations into the footcare industry, as this is
associated with more affordable, user-friendly products. Thus, the greater
access and use of 3D and 4D foot scanners depends to a large extent on its
costs. Cheaper and portable 3D and 4D foot scanners should be achieved
without sacrificing quality, accuracy and precision.
The feet digitisation in dynamic conditions (4D) is strongly recommended in
both, the prescription and design phases of customised orthopaedic
footwear/insoles/orthotics, as it provides data about the variations in the
anatomical structure of the foot that are produced in a dynamic position (i.e.
load distribution). The foot is a flexible structure and the dynamic behaviour
of feet is quite diverging among different feet. This is not recorded by static
scanners (3D). However, the use of 3D scanners is enough in those cases
where the clinician only needs a 3D model.
RELATED INNOVATION - Development of a really practical, high quality and portable scanner, which
generates a 3D file ready to be used in a CNC machine to make the lasts.
- 4D scanner that integrates data from the contact pressure between the
foot and the shoe
- An orthopaedic footwear/insole production software connected to 4D
scanners
this software and devises
PATIENT JOURNEY HEALTHCARE ROUTE:
- Clinic: Clinical assessment, data collection, fitting, agreed specification
KEY ENABLERS CAD software developers; orthotic and footwear researchers; IT and
footwear research centres, universities expert in biomechanics.
Research Priority
RP1.3
Improved CAD/CAM tools for the manufacturing of custom
therapeutic footwear and insoles
SHORT DESCRIPTION This research priority is also in line with the e-manufacturing innovation
domain of the Factories of the Future multi-annual roadmap, specifically
with the domain 1: “advanced manufacturing processes”, sub-domain 1.1.1:
Manufacturing for custom-made parts, which is one of the research and
innovation priorities identified in that roadmap. As identified in that
document, for all custom manufacturing it is necessary to have quick
realisation from design to production in one process step, research should
address the need for seamless data integration across the process chain.

In this sense, CAD (and CAM) plays a crucial role, as it enables the design of
a virtual product, which can be tested prior to being manufactured, what it
reduces considerable the number of trials and prototypes. Therefore,
improved CAD/CAM tools for the manufacturing of custom therapeutic
footwear and insoles would have an impact on the time to market, and
generally the delivery time of the orthopaedic companies.
RELATED INNOVATION - CAD tool allowing for the design of footwear components such as the sole
and the orthotics, considering the different foot conditions of patients:
diabetic foot, older foot or obese foot (and connected with a 3D prescription
tool).
- New tools for using CAD/CAM alongside new training courses
- New tool for comparing a virtual shoe model with the scanned 3D foot in
movement and highlighting critical areas such as excessive contact pressure
areas.
- Developments in the CAD/CAM and product development tools, as well as
in the data integration themes.
- Development of perceptive computational models that enable the
perception perceived by users to be adapted to 3D CAD operations aimed at
modifying the geometry of the designed lasts, insoles or orthotics.
- Improved/new fast and accurate methods to reconstruct lasts/feet
digitised surfaces.
this software and devises.
4. To achieve greater accuracy, speed in design and cost effectiveness in the
8. To increase user’s satisfaction by improving fit, comfort and speed of
product provision
PATIENT JOURNEY HEALTHCARE ROUTE
- Clinic: fitting, clinical assessment / data collection, outcome
- Manufacture: specification/ design, make last
RETAIL ROUTE
- Design, specification
KEY ENABLERS Orthotic and footwear researchers; organisations that produce patient
applications and feedback tools; private podiatry clinics, diabetic foot units
or podiatry units at hospitals, orthopaedic footwear manufacturers,
footwear technology centres.

Research Priority
RP1.4
Hybrid human-robot environments in combination with additive
manufacturing systems
SHORT DESCRIPTION Robotic devices continue to evolve and, as they become less expensive and
more widely disseminated, will likely become more used by new sectors, in
new applications. Manufacturing by means of robotic systems leads to
higher accuracy and quality. In addition, it helps speed up the
interconnection between the design and the manufacturing stages.
The use of robots within the footcare industry would entail facing a new
paradigm in the way orthopaedic footwear manufacturers produce their
products. In addition, the combination of industrial robots with additive
manufacturing systems would be also a great advancement for the sector.
For example, the quick manufacturing of custom made foot orthoses,
insoles, etc., in a clinically led, that are immediately tested in the patient
would help the clinician to assess the efficacy of the clinical prescription
before manufacturing, and consequently, this would lead to a more
efficient, faster and cheaper provision of footwear, and therefore a higher
patients’ satisfaction.
The introduction of robots in the production line would also speed up the
production of orthopaedic footwear/footwear components. Thus, the use of
industrial robots, in combination with additive manufacturing systems,
would allow to produce complex models as well as new orthotic design
features on the basis of 3D CAD data without intermediate steps that
consume money, material and time.
RELATED
INNOVATIONS
- Development of small robots for the manufacturing of some footwear
components at the clinics, with the combination of additive manufacturing
systems.
- Integration of robots in the production line.
- Development of specific software tools for robotic manufacturing linked
with CAD design tools and CAM tools for machining toolpaths on robotic
systems.
the software tools and robots.
CHALLENGES 3. To reduce the number of fitting tests by achieving greater accuracy, speed
in design and cost effectiveness in the specification/design phase
4. To achieve greater accuracy, speed in design and cost effectiveness in the
product provision
- Manufacture: all
- Clinic: fitting, clinical assessment/ data collection
RETAIL ROUTE
- Manufacture: all
KEY ENABLERS Robotic manufacturing companies, Universities and research centres experts
in robotics, footwear technological centres, private podiatry clinics, diabetic
foot units or podiatry units at hospitals, the European Footwear Technology
Platform, other technology platforms (national or international), National
Footwear associations.

Research Priority
RP1.5
Novel supply chain approaches & organisational models
SHORT DESCRIPTION The manufacturing of customised orthopaedic footwear in a global world
demands new approaches as well as new operation strategies of their supply
chains. As said in Factories of the Future multi-annual roadmap, regarding
the production of highly customised products, such as customised
orthopaedic shoes, new technologies, structures and ICT systems are
needed to establish ad hoc supply. Within the footcare industry, ICT can help
to establish a better flow of the information and materials throughout the
value chain and also to get a higher standardisation of the information
and/or processes, as currently the type, quantity and quality of information
depends on each company’s business scale and model, i.e. the range of
materials available and geometry features are limited by the supplying
company. The prescription sheet frequently is a manual paper based
prescription that it is not standard, the terminology used within the whole
process is also mostly different, etc. In this sense, to carry out initiatives
aimed at the development of a standard system for the exchange of data
and information that is understood and shared by the footcare value chain’s
agents, would be a great advancement.
The high diversity and complexity of the footcare sector in each country is
one of the biggest barriers for the internationalisation of the orthopaedic
footwear companies. In this sense, the adoption of a standard system for
the exchange of data and information would also enable the
internationalisation of these companies. Related to this, in order to become
internationalised, an orthopaedic footwear company would have to change
its business model and the way it manufactures, commercialises, sells and
distributes its products. Therefore, in order to get a better flow of the
information and materials throughout the footcare industry value chain and
a higher standardisation of the information and/or processes, new and
innovative organisational models with novel supply chain approaches and
processes need to be sought and adopted globally.
RELATED INNOVATION - Creation of a platform where all agents of the value chain use and share
the information generated in the different steps of the supply chain.
- New business models for the manufacturing and selling of customised
orthopaedic footwear.
4. To achieve a greater accuracy, speed in design and cost effectiveness in
the last design and manufacturing phase
product provision
PATIENT JOURNEY HEALTHCARE ROUTE (all stages)
RETAIL ROUTE (all stages)

KEY ENABLERS Orthotic and footwear researchers; clinicians, manufacturers, suppliers, the
European Footwear Technology Platform, National Footwear associations
and other technology platforms (national and international).
Research Priority
RP1.6
Biomechanical virtual shoe test bed based on augmented and virtual
reality
SHORT DESCRIPTION This priority is related to the development of tools aimed at testing the
product before its manufacturing. A virtual shoe test bed that integrates
data from different sources, mainly biomechanical parameters, would help
the clinician to prescribe a more accurate treatment and, as a result, a
better fit customisation would be obtained and the number of trials would
be reduced.
In addition, the use of a virtual shoe test bed in podiatry clinics, podiatry
units at hospitals, diabetic foot units or shops, would help the patient to
choose the most suitable orthopaedic shoe according to a wide range of
models available. This would enable the display of the full catalogue of
footwear models, and not only those which are in stock. As a consequence,
consumer satisfaction as well as the time the patient wears the orthopaedic
footwear increases, what it is crucial in the case of patients with diabetic
foot syndrome.
RELATED INNOVATION - A 3D Shoe virtual tester by means of augmented reality techniques.
- To improve the performance of Augmented and Virtual reality equipment.
- To reduce the cost of Augmented and Virtual reality equipment.
the AVR equipment.
assure minimum quality levels at each step of the supply chain.
design and cost effectiveness in the specification/design phase.
last design and manufacturing phase.
5. To improve fitting and patients’ comfort perception.
product provision.
- Clinic: fitting, data collection, order
RETAIL ROUTE
- Retailer: Design, user opinion, try fitting
KEY ENABLERS Private podiatry clinics, diabetic foot units and podiatry units at hospitals,
footwear technological centres, universities and research centres experts in
biomechanics.

The following picture summarize the research priorities across the footcare value chain and shows how to
better integrate the actors by mean of the development of the priorities.
Figure 28: Research priorities & Patient Journey - WG1
5.2 Towards reduced foot infection
Bacteria can cause an infection that can develop in
the skin of the foot or through corns, calluses,
blisters, hangnail or ulcers. Diabetic patients,
elderly and obese are at a much higher risk of
developing foot infections than the general
population. Not only that, but there are also
footwear factors (e.g. temperature, humidity,
mechanical irritation, chemicals) that are
associated with microbial growth and that can lead
to more serious bacterial infections.
Diabetic patient may develop many types of foot
wounds, thus, early diagnosis of foot infection can
potentially reduce the incidence of infection and
therefore reduce risk of foot amputation. In addition to diagnosis, the development of news nanofiber-
based biomaterials for wound healing applications is of vital important to reduce foot infections in
diabetes, elderly, and obese. As a result, the aim of this working group is to point out the most relevant
research priorities that could help reduce foot infection and hygiene issue in the Sohealthy project
populations.

5.2.1 Challenges
The main important challenges, which have been identified for this working group, are as follows:
1. Lack of detection/measurement methods for shoe temperature and humidity.
There are currently difficulties with measuring foot-skin
temperature and shoe micro-climate when a shoe is worn, as the
presence of sensors and connecting leads can cause undesirable
reactions from the skin and disturb the natural foot-shoe
environment. The equipment needs to be fully portable and not
influence the environment which it is measuring. The sensitivity is
key in terms of measuring fluctuations with and without the foot
in the shoe. Additionally, the availability of these devices is within
experimental situations, which may not reflect the real world. The
development of affordable, portable and non-intrusive devices
would make their use more wide such as in clinic or within the patients’ daily life. Establishing appropriate
outcome measures and values for what specifically is a “risk” is essential to make such technology
developments are worthwhile.
2. Lack of efficient way of measuring risk of infection in the context of footwear.
Measurement is very important, because in the absence of appropriate clinical measurement tools (e.g.
bacteria, fungi type) the clinician is unable to advise the patient on the correct footwear design and
materials for the patient’s feet. Within this context, improvements or developments in measurement
technologies and methodologies could act to provide valuable information to inform future treatment or
interventions. This development incorporates technology for both diagnosis and monitoring of foot
infections, which is not widely available in clinic. Alongside such developments in technology, establishing
valid and reliable outcome measures is also essential to make the integration of this technology
worthwhile.
3. Lack of compounds (chemical, natural or synthesized compounds) allowing the microbial load of the
feet to be reduced.
This challenge relates to antimicrobial materials which are used to reduce and prevent bacterial infection,
but the problem is that there is a lack of the chemical and natural compounds that allow the microbial load
of the feet to be reduced, thus avoiding the risk of infections within footwear manufacture. Where these
materials are utilized within the footcare industry (e.g. silver technology in socks in the UK) the efficacy of
the material is not always known. The application and value of these materials requires knowledge of the
specific bacterial fungal load within shoe in specific populations. Combined with societal influences (e.g. the
use of hosiery within populations) would enable specific recommendations relating to their use and
method of application (e.g. footwear liner versus sock).

4. Nanomaterials are not available in footwear.
In order to reduce and prevent foot infection, we need to
implement an integration of different materials and
compounds. Nanomaterials are of high value in the footwear
industry. As the nanomaterials can take control of bacteria, they
are increasingly demanded by footcare professionals and
manufacturers of protective footwear. They are currently not
widely available or are too expensive to be widely utilized
within footwear manufacture and design. The expense of the
process to develop and manufacture the nanomaterials for the
footwear could drive the price up of the end-product, limiting
the provision of the footwear/footcare to wider users,
particularly relevant when we consider the socio-economic status of some diabetic and elderly patients.
5. The price of the materials is very expensive.
The materials utilized for the manufacturing of personalized footwear and components for people with
diabetes, people who are obese and the elderly is of great importance. In addition, the development of
new functional and smart materials will open up possibilities so far not explored by the footwear industry,
allowing it to meet the expectations of increasingly demanding customers and thus become more
competitive. According to a materials’ value and its important role in footwear manufacturing and health
care applications, advanced materials that could suit the high risk foot are very expensive. This expense of
the raw material for the footwear could drive the price up of the end-product. This would make the
provision by national health care services limited (to fewer patients or less pairs per patient), or the product
unaffordable for the standard user if the cost is not covered by their health provider.
6. Design and properly fitted are recommended for make last and lack of form specialist.
The microbiology of specific population’s feet can leave the foot more susceptible to risk from poor fit or
poorly designed footwear. For example the high risk foot can develop wounds that can particularly lead to
amputation, for which the design of a properly fitted shoes is very important to prevent such injuries. This
challenge encompasses both the material of the footwear and the last form utilized to define the
morphology and size of the shoe. Specific guidelines based on data and feedback from patients are
required to aide these decisions, which requires technology advances to develop measurement methods to
establish what is appropriate for specific populations/patients and also feasible in clinical practice.
7. Patient education for different conditions and in different regions
The aim of patients’ education is to improve their knowledge, skills and confidence, enabling them to take
increasing control of their own condition and integrate effective self-management into their daily lives.
High-quality structured education can have a profound effect on health outcomes and can significantly
improve quality of life. This education can provide the patient with skills to manage their own foot infection
or risk of infection within their daily lives, or how to react to changes in their foot status. The requirements
for patient education vary based on both the patient’s condition and also the region. This is due to specific
patient risks due to their condition, societal influences and environmental influences, which interact to
influence both the users risk and their management. Tools such as E-learning platforms and communication
materials may educate patients and the manner of the communication must be patient and region specific
to select the correct message and method to effectively influence users and thus outcomes.

Research Priority
RP2.1
New microbiology procedures to detect microorganisms colonization
SHORT DESCRIPTION Prevention of higher risk of foot ulceration requires foot examination more
often for early detection of potential risk factors. This can decrease the
frequency of wound development that leads to ulcers and potentially to
amputation especially in the diabetic foot therefore, it is necessary to
improve new microbiology procedures. Thus, the aim of this research
priority is to improve and develop microbiology procedures to detect
microorganism colonization in order to reduce foot infection.
RELATED INNOVATION This priority will include testing materials in vivo for their ability to maintain
an appropriate in shoe environment. Relating to development and to the
design of novel footwear materials, e.g. insole sensors and materials that
could change colour for temperature and humidity measurement.
CHALLENGES 1. Lack of detection/measurement methods in shoe temperature and
humidity.
2. Lack of efficient way of measuring risk of infection in the context of
footwear.
PATIENT JOURNEY HEALTHCARE:
Clinic: Clinical assessment/Data Collection.
Manufacturing: Specification/Design, components.
KEY ENABLERS Research centres with clinical, technological and materials experts. Research
centres with clinical knowledge to conduct usability and outcome trials.
Research Priority
RP2.2 a
New materials with nanotechnologies with antifungal, bactericidal
or moisturising agents
SHORT DESCRIPTION Nanotechnology is an emerging science and with growing use particularly in
developing new materials. The advance in nanotechnology can produce
healing or antifungal effects especially for the diabetic, obese and elderly
foot. It would be beneficial to have a material that can respond to foot
changes, for example if the skin surface moisture falls below a predefined
threshold level, this would be sensed by the material and then triggered to
release an appropriate amount of moisturiser.
RELATED INNOVATION The first stage would be to scope what is currently available in the market
and the technology behind the products before implemented a step change
in material design and to develop appropriate nanomaterials for integration
into footwear components e.g. uppers and liners. There is hosiery that is
impregnated with moisturisers and antimicrobials and sectors may have
developments, which can be applied to foot health.
CHALLENGES 3. Lack of compounds (chemical, natural or synthesized compounds)
allowing the microbial load of the feet to be reduced.
4. Nanomaterials are not available in footwear

5. The price of the materials is very expensive
Manufacturing: Specification/Design, Components
Clinic: Clinical assessment/Data collection
KEY ENABLERS Material experts.
Nanotechnology research centres.
Research Priority
RP2.2 b
New biomaterials with antimicrobial properties combined with
novel dressing materials
SHORT DESCRIPTION Chronic and complex wounds represent one of the biggest challenges to
obese, elderly, and diabetic people because they are difficult to heal.
Therefore, this priority has to do with improvement and development of
new biomaterials with antimicrobial properties, so as to control foot
infection and release antifungal in many pathological situations (elderly,
diabetes, obesity), in which the risk of foot infection is higher.
RELATED INNOVATION The innovations could be used in all shoes materials. Developing new
biomaterials with antimicrobial properties combined with novel dressing
materials will be helpful for these target groups in order to produce adapted
shoes and footwear, reducing the cost. Also providing shoes with innovative
and effective biomaterials capable to minimize the formation new ulceration
would be helpful.
CHALLENGES 2. Lack of efficient way of measuring risk of infection in the context of
footwear.
6. Design and properly fitted are recommended for make last and lack of
form specialist.
Manufacturing: Specification/Design, Components
Clinic: Clinical assessment/Data collection
KEY ENABLERS Clinical, technological and material experts.
Clinical sites or patient groups for usability studies.

Research Priority
RP2.3 a
Innovative visualization software for managing pressure and
temperature information
SHORT DESCRIPTION Development of pressure visualization software that allows visualizing and
managing pressuring and temperature is important, because in the absence
of appropriate clinical measurement tools the clinician is unable to advise
the patient on the correct footwear design and materials. This is especially
key for the at risk diabetic, elderly and obese feet. The system shall also
support the analysis of the foot status when it is under shearing force, which
is currently lacking in clinical measures, but a key risk to foot skin.
RELATED INNOVATION Finding relevant inventions for the monitoring of foot temperature as a
means of early detection of foot disorders in high risk foot and to describe
available technologies in this area and to develop and provide suitable shoes
with adapted insole foot wearing in order to prevent foot complications.
humidity.
6. Design and properly fitted are recommended for make last and lack of
form specialist.
Clinic: Fitting/Outcomes.
KEY ENABLERS Clinical technological and material experts.
Software experts.
Research Priority
RP2.3 b
New smart textiles and materials with sensors to monitor
parameters
SHORT DESCRIPTION The existence of a system that can measure several parameters
simultaneously could be of great benefit not only for research purposes but
in the clinical setting as well. This priority deals with materials by attempt to
find smart and intelligent materials. These smart materials should be
designed to reduce infection in high risk foot by using humidity regulation
and pressure reduction.
RELATED INNOVATION Development of an innovative smart textile based on fiber optics is required;
this allows measuring simultaneously plantar pressure, plantar temperature,
and lower extremity joint angles.
- New nanofibers-based biomaterials for wound healing applications
- New phase change materials with improved self-regulation temperature
- Materials able to reduce high local pressure
humidity.
2. Lack of efficient way of measuring risk of infection in the context of
footwear.

Clinic: Fitting/Outcomes
KEY ENABLERS Clinical technological and material experts
Research Priority
RP2.4
International standardized guidelines for orthopaedic footwear
SHORT DESCRIPTION This research priority focuses on developing an international standardised
guideline about appropriate footwear for the high risk diabetic foot. The
knowledge generated by the innovations and developments will need to be
translated to all the stakeholders in a variety of methodologies and
languages.
RELATED INNOVATION Standard guidelines and methods to present or portray these.
CHALLENGES 7. Patient education for different conditions and in different regions
Clinic : Healthcare professionals/Patient decision, Agreed design
KEY ENABLERS Patient organizations and healthcare professionals. Researchers and experts
relating to diabetic foot.
Research Priority
RP2.5
Education and training for patients with a high risk foot
SHORT DESCRIPTION Diabetic patient needs to be made aware of the specific complications and
risks relating to their foot. Complications and risks can be prevented,
reduced or managed with careful footcare and inspection. If complications
do occur, daily attention will ensure that they are detected before they
become serious. It may take time and effort to build good foot care habits,
but self-care is essential. In fact, when it comes to foot care, the patient is a
vital member of the medical team. This stage deals with providing patient
with competitive education to improve and manage their patient journey.
RELATED INNOVATION E-learning platform and other communications materials.
CHALLENGES 7. Patient education for different conditions and in different regions
Clinic : Healthcare professionals/Patient decision, Agreed design
KEY ENABLERS Patient organizations and charities.
Healthcare professionals.
Educators and stakeholders in health care.

The following picture summarizes the research priorities across the footcare value chain and shows how to
better integrate the actors by means of the development of the priorities.
5.3 Towards material innovations
Footwear interventions are used within clinical practice in order to
treat or prevent some foot diseases. More precisely, in the case of
people affected by diabetes and obesity and the elderly, functional
footwear and footwear components (shoe inserts, orthotics, etc.)
are required to fulfil their needs in order to prevent injures and/or
to improve comfort and wellbeing. For instance, shoe inserts and
orthotics are used as clinical interventions in a variety of foot’s
pathologies affecting the target groups. In these applications,
functional footwear and components are used for many different
purposes, for example to align the skeleton, improve damping of
impact forces, control foot and leg movement, improve comfort
and reduce the frequency of injures.
Attainment of these objectives is affected by the proper selection of the materials as well as shoe features
for footwear. Both aspects influence the performance or effectiveness as well as durability of the functional
footwear as clinical intervention. Footwear recommendations for people affected of diabetes and obesity,
as well as for elderly should be based on their specific characteristics such as the individual’s activity level
and the presence of foot deformities and/or elevated plantar pressures.

These distinctive features require materials with specific properties and new functionalities to fulfil their
requirements. Thus, footwear materials can be chosen or be developed for many purposes, for example
aesthetical, structural, healing, preventive (antimicrobial), comfort and wellbeing, durability.
For instance, materials able to alleviate pressure may be positioned in specific locations to redistribute
plantar pressures, according to specific patient demand. This is the case of people with callus, plantar
hyperkeratosis, corns, warts, pes planus, oedema, etc. and also people with diabetes, who should wear
specific insoles that incorporate materials to reduce pressures at specific anatomical sites. This reduces the
risk of damage to tissue in addition to providing a higher comfort sensation and wellbeing. Self-regulated
materials relating to temperature and humidity are important to provide an appropriate foot microclimate
for reducing the risk of ulceration and improving “comfort sensation”. Other examples include materials
with antimicrobial and antifungal properties aimed at reducing the risk of infection and increasing
proprioception, and materials which act as biosensors or biomarkers could be incorporated in order to
record patient’s information.
Therefore, the development of new materials for personalised footwear and components for people with
diabetes, people who are obese and the elderly is of great importance to offer more effective solutions and
a higher range of functionalities aimed at palliating and/or alleviating many of these target group’s foot
problems. Furthermore, the development of new functional and smart materials will open up possibilities
for the footwear industry, allowing it to meet the expectations of increasingly demanding customers and
thus become more innovative and competitive as a sector.
With that aim, this working group was created in the framework of the SoHealthy project to provide
further insights relating to materials innovation, providing more suitable materials based on scientific
knowledge for use within end-user products in addition to within research and development in the footcare
and footwear sector.
5.3.1 Challenges
The key challenges identified relating to materials innovation for the healthcare route in the patient
journey are as follows:
1. To carry out more clinical research studies on the behavior of the different foot areas in order to use
proper materials aimed at reducing the pressure in the foot.
Clinicians should know well the behaviour of the different areas of the foot as well as how the different
materials behave. For example, the material and structure of the midsole should withstand increased
repeated loading and disperse increased shock/loading, the insole and the outsole can be made of
materials aiming to increasing in local blood supply and all components should be designed and made of
material conceived for longevity and aimed at increasing proprioception. However, clinicians do not have
detailed information about the dorsal area of the foot behaviour and how it interacts with the footwear
upper. Further information could also be gained regarding the behaviour of the foot plantar area in the
populations and the influence of material combinations on this characteristic. Consequently, it is needed to
carry out more clinical research studies on the behaviour of the different foot areas in order to clinicians
choose the most suitable materials in each case and pathology.

2. To collect and process data from different sources to advice the clinician for a right prescription,
including patient’s daily activity profiles
Nowadays the clinician can get information about the patient’s feet from different sources with a higher or
lower degree of technological development such as scanners, manual measurements, foot pressure plates,
gait analysis, etc. Despite this availability of data, this information is not integrated or collated by a unique
tool offering the clinician a global vision of the problem. In this sense, it would be a great challenge to
develop a knowledge-based software tool to support the design phase that includes information from
different sources, for example, biomechanics information about each area of the foot as well as
information about the behaviour of each material depending on the foot area implicated and the
pathology. This would enable the clinician/manufacturer be able to design bespoke footwear for each
patient depending on the pressure location. For developing such a tool, the footcare sector needs to
generate, transfer and exchange the clinical, technical and production knowledge to define the guidelines
for the design of a fashionable, customized and healthy footwear, according to each target group
requirements. The study on the effects of footwear component materials on function and comfort should
also take into account patient’s daily activity profiles, including this information at the design phase, in the
knowledge-based software tool mentioned before, thus more suitable footwear and footwear components
will be produced. To highlight that the development of a prescription tool is one of the first working group’s
research priorities.
3. To reduce the risk of foot infection, falls and increase proprioception
Footwear materials choice should aim to improve the stability and grip during gait of people with diabetes,
obesity or the elderly. In addition, materials with antimicrobial properties might be used to prevent or
reduce foot infection risk.
Ulcer infection is a devastating complication very commonly related to the diabetic foot, and the main
cause of amputations. Controlled release of antibiotics at the right place and the right time is a key
functionality that can be provided by nanoencapsulation technology. A timely and targeted release
improves the effectiveness of antibiotics, broadens their application range and ensures optimal dosage. In
addition, metallic nanocomposites, such as silver and gold, show outstanding antimicrobial properties, so
they could be used as biocompatible solutions for foot infection prevention. Furthermore, the use of
temperature biomarkers or biosensors, which change colour could be very useful in the early detection of
foot ulcer infection and provide information to the patient to manage their own health condition.
Relating to falls, the insoles or insocks should be made of materials or vibrating surfaces or textured to
increase proprioception. For such purposes, polymeric nanocomposites could provide a new generation of
materials for footwear applications that might improve the features mentioned above. These materials
combine thermal, electrical or thermo-electrical properties, which also provide higher environmental
durability because of their lower water absorption and enhanced ageing properties. Related to this,
nanofibers have become an exciting area in biomaterials development, as many studies have reported their
feasibility in various applications, such as promoters for tissue cell adhesion and encapsulation of drugs and
/or antibiotics (i.e. nanoparticles with antimicrobial properties). Clinicians should be made aware of the
application and availability of these new materials and their properties in order to make the best material
choice in each case.

Relating to ulcer treatment, one of the main research lines have to do with the development of new
antiseptic dressings. It is a challenge for clinicians to choose the right dressing and technique available to
best suit their specific patients needs. To this end, clinicians should have basic knowledge of dressings for
correct application and design, and the wound should be monitored closely to ensure effective healing.
4. To increase the range of materials that can be used for AM for the production of orthoses, lasts,
insoles, etc.
As stated by the first working group “towards more efficient provision”, the development and use of new
production technologies is crucial to improve time-consuming tasks and processes that delay the delivery of
the shoes. One of these technologies is additive manufacturing (AM), which offers high-quality bespoke
products quickly and efficiently, which can be highly personalized to individuals.
However, the design of custom foot and ankle orthoses is heavily restricted by the materials and methods
used to fabricate the device. To increase the range of materials that can be used for AM is one of the main
research topics currently, but more research is still to be done on material tolerability in terms of weight,
temperature and force and to introduce more groups of materials for AM. Other challenges relateing to this
issue would be to reduce the price of raw materials, to recycle the scraps, and to increase machinability.
Furthermore, new 3D structures produced by AM should be investigated in order to obtain suitable
biomechanical properties according to the patient need.
5. To change the mindset towards the use of the new materials and technologies, especially in the
north-African countries.
Diabetes, obesity and ageing and their health consequences on feet are global problems with a high burden
in terms of cost and societal impact. Despite this, the resources available to face these diseases vary greatly
in each country. The degree of technology development is also different and consequently it is necessary to
undertake some actions aimed at raising awareness of the importance of using the new advances of the
sector to better meet these patients’ needs. Therefore, culture needs to change to make CAD-CAM tools
and technologies favorable when compared to existing methods.
6. To normalize the appearance of the orthopaedic footwear in order to increase patients' adherence to
orthopaedic footwear advice
When possible, materials should enable the design and manufacturing of an “aesthetically attractive” shoe,
according to the fashion trends, in order to meet patients’ preferences. Nowadays, patients are asking for
more and more fashion and comfort products, we cannot forget that patients are people with feelings and
emotions. Patients are immersed in a cultural context, people that want to live a “normal” life, despite
their condition. Consequently, it is also important to normalize the appearance of the orthopaedic
footwear, taking into consideration the “aesthetical” parameters of a shoe and offer the patients several
shoe models options (in particular for women). Several surveys have shown that patients chose not to wear
their orthopaedic footwear because it did not appear stylish enough, which contributes to low adherence
levels reported within orthopaedic footwear.
7. To improve clinical assessment and data collection process for improved treatments
Clinical assessment and validation of effectiveness of customized orthoses and footwear is fundamental to
continuously improve the knowledge and the best practices used by the clinician to design a product. To

this end, the development of biosensors and markers to improve and inform clinical assessment and data
collection process is needed, as well as novel tools to manage this information and improved data storage
systems. This would enable the assessment of the suitability and efficacy of materials for different footwear
functions and uses.
The key challenges identified relating to materials innovation for the retail route in the patient journey is as
follows:
8. To design and manufacture “healthy” footwear with materials that improve comfort and help to
prevent foot pathologies
From the prescription to the provision of footwear, the final goal is to manufacture a footwear and/or
footwear component aimed at preventing, alleviating or palliating foot problems related to diabetes,
obesity and ageing. Therefore, the development of new materials should be aimed and focussed specifically
to fulfil this objective.
As aforementioned in challenge no. 3, to collect and measure relevant data from the foot in a real
environment, materials must be compatible with monitoring systems (embedded sensors, actuators, etc.).
Thereby sensors can be incorporated into shoes for monitoring the pressure applied to the sole for gait
analysis and other parameters. Sensors play an important role in the identification of the higher foot
pressure areas and therefore to pressure-reduction by using off-loading materials in those areas, which can
aid foot health and comfort.
In addition, the use of adhesives with antimicrobial properties can promote a higher hygienic environment
as one of the main causes for foot infections caused by fungi is the lack of footwear hygiene and the fact
that the foot is enclosed in a closed, poorly ventilated space. This is even more important in diabetic foot
infections (DFIs), where infection already exists. For that reason, the use of these adhesives in the
therapeutic footwear manufacturing process could help in the creation of a more hygienic environment.
9. To get a higher standardisation in the manufacturing, design and testing processes
This challenge is related to the need of establishing general footwear requirements for each target group
(diabetes, obesity and the older), including materials specifications. This would help to design and
manufacture customised footwear with improved performance, quality and reliability.
Standards provide organisations with a common basis for mutual understanding. They are especially useful
for communication, measurement, commerce and manufacturing and should ensure that a product will
satisfy a series of specific quality criteria, corresponding to customers’ requirements.
Therefore, the development of European standards would be a great advance as it would ensure the quality
and safety of footcare products, gain knowledge about new technologies and innovations, reduce costs,
eliminate waste and improve efficiency. Additionally, it would make trade between countries easier and
fairer by ensuring compatibility and interoperability of components, products and services.

10. To assure that the functional properties of the new or existing materials remain unchanged during
the manufacturing process
When developing new materials, it is necessary to assure that its properties and functionalities do not
change during the different manufacturing processes. Therefore, the new materials must be manufactured
in the properly selected technological process, keeping the required shape and other geometrical features
and also forming the required material structure, ensuring the expected mechanical, physical and chemical
properties of the final product.
In conclusion, manufacturing conditions should assure that functional properties of the materials remain
unchanged during the whole process, including aspects related to cross contaminations. In order to achieve
this, the new material can imply the development of a new manufacturing process technology, or the
improvement of the existing processes.
11. To develop more sustainable, durable and biodegradable materials
Far from being a fad, Eco-fashion or "sustainable clothing" movement is gaining more and more importance
due to environmental issues. All industries (including the footwear industry) need to be aware of, and
respond to, the opportunities provided by the growing demand for recyclable and biodegradable
fabrics/materials that seeks to create garments and footwear that are sustainable at every stage of their life
cycle, from production to disposal. Thereby the development of more environmentally friendly materials is
a challenge nowadays, as consumers are asking more and more of the use of green and biodegradable
biopolymers or natural fibres.
We can already find some examples of footwear made of organic cotton, bamboo, recycled tyres rubber,
eco-friendly certified leather, etc. in the market. The experts state that bio-based biomaterials represent an
emergent market with a huge potential, which will increase in the following years.
Those biobased materials can have interesting applications within the footcare sector. For instance, we can
already find soles made of natural plant fibers that have interesting health care advantages such as
moisture permeability, air permeability and sweat filtration, skin diseases resistance, and good efficacy to
reduce the symptoms of skin conditions such as those which may contribute to foot odour.

Research Priority
RP3.1
New smart materials with new appropriate functionalities for health
care application
SHORT DESCRIPTION This priority is in line with the current trend that moves away from traditional
uses of materials and seeks increased complexity and 'intelligence' in terms of
applications. Thus, relating to the diabetic foot; footwear and footwear
components should be designed for reducing the risk of ulceration to the foot,
that implies the use of materials with thermal and humidity regulation and / or
antimicrobial properties, etc. and the insoles should incorporate materials to
reduce pressure at specific anatomical sites or other functionalities.
Therefore, this priority is related to the development of a wide range of
materials aimed at preventing, palliating or alleviating foot problems related to
the diabetic, obese and older foot.
RELATED
INNOVATIONS
- Definition of new functionalities
- New materials aimed at improving the stability, grip and flexibility of people
with diabetes, obesity or the elderly.
- New nanofibre-based biomaterials for wound healing applications
- New phase change materials with improved self-regulation temperature
- Materials able to reduce high local pressure
- Biomaterials for the treatment and prevention of foot pathologies
- Natural materials with hydrophobic properties
- Nanomaterials with improved breathability
- Biofunctionalisation of nanoparticles for targeted release of active substances
- Antiallergenic materials avoiding critical substances
- Biomaterials improving skin regeneration
- Development of new materials and adhesives that release antifungal,
antimicrobial or moisturising agents (i.e. microcapsules)
- Knowledge-based information on the effects of the customised footwear on
function and comfort to develop customised footwear and components
CHALLENGES 3. To reduce the risk of foot infection, falls and increase proprioception
8. To design and manufacture “healthy” footwear with materials that improve
comfort and help to prevent foot pathologies
- Clinic: healthcare professional decision, agreed design, fitting, clinical
assessment, data collection
- Manufacture: specification/design, make last.
KEY ENABLERS Universities, Research centres, European Platforms, Manufacturing Associations
Research Priority
RP3.2
Application of biomechanical parameters in the proper selection of
materials for customised footwear and insoles
SHORT DESCRIPTION Materials, as well as shape, are critical to the production of customised
comfortable, safe and healthy footwear/footwear components for each target
group. In this sense, materials selection should be informed by rich knowledge
of foot behaviour and foot tissues with which the material will interface. In
addition, the quantification of the biomechanical behaviour of materials (such

as dynamic stiffness and energy return) and the assessment of shock absorption
properties of insoles and soles will allow for improved treatments and reduced
production costs.
Consequently, this priority is closely related to the need to collect more
information about the biomechanical behaviour of the different foot tissues and
areas. and quantifying the biomechanical behaviour of each material. This will
enable the appropriate material selection dependent on the foot areas
implicated and the foot pathology, therefore the clinician/manufacturer would
be able to design a bespoke footwear/footwear component to each patient
depending on the pressure location.
RELATED INNOVATION - A device capable to capture and store data from the patient in a real life
situation in his/her day-to-day routine. Namely, pressure, activity, temperature
and humidity information.
- A simulation tool to study the whole shoe behaviour according to the
parameters and materials chosen.
- New functional materials which are able to interact with feet according to their
biomechanical requirements at any time.
- Development of cost-effective materials according to biomechanical
requirements.
- Development of standard methods for evaluations.
CHALLENGES 1. To carry out more clinical research studies on the behavior of the different
foot areas in order to use proper materials aimed at reducing the pressure in
the foot.
2. To collect and process data from different sources to advice the clinician for a
right prescription, including patient’s daily activity profiles.
comfort and help to prevent foot pathologies.
- Clinic: agreed design & specification, specification/design, clinical
assessment/data collection.
KEY ENABLERS Universities, Research centres, European Platforms, Manufacturing associations,
Healthcare professionals
Research Priority
RP3.3
New testing methods to evaluate new materials functionalities
SHORT DESCRIPTION This priority is related to the priority RP3.1., which relates to the development
of new materials with new functionalities. The development of new testing
methods is crucial if the aim is to evaluate the suitability of the new developed
materials alongside with their functionalities.
This priority entails the assessment of the existing testing methods and how
these can be applied in the case of new materials and new patients.
RELATED INNOVATION - A material comfort perception test based on user opinion data
- Development of standards and specifications for analysis
- Simulation tools as validation method

CHALLENGES 9. Higher standardisation in the manufacturing, design and testing processes
10.To assure that the functional properties of the new or existing materials
remain unchanged during the manufacturing process
assessment/data collection
RETAIL:
- Brand: design, specification and source Design, specification
KEY ENABLERS European Bodies of Standardisation, Research Centres, Material manufacturers.
Research Priority
RP3.4
New materials with sensors and biomarkers as diagnosis and evaluation
tools
SHORT DESCRIPTION This priority has to do with the development of new materials for the rapid
detection and prevention of foot diseases. These new materials would
incorporate sensors, biomarkers, etc., as for monitoring foot plantar pressures
and other relevant parameters (temperature, humidity, etc.). This would lead to
a better and faster diagnosis and treatment of foot conditions.
These materials should be compatible with monitoring systems that collect
relevant data about the patient’s daily activity and other information, such us
biomechanical information (relation with priority RP.3.2.). All together would be
very useful in the prevention of many foot pathologies.
For example, once a diabetic foot ulcer is produced, it must be monitored
closely to ensure effective healing. Thereby, the use of sensors is promising for
the monitoring of relevant patients’ foot parameters.
The development of materials that can change colour in response to
temperature and other parameters as a way of enabling the management of
foot temperature and reducing risk to the foot health. are also included within
this priority.
The use of these materials can help healthcare professionals and patients to
control and monitoring foot temperature changes and then limit the incidence
of disabling conditions such as foot ulcers and lower-limb amputations.
RELATED
INNOVATIONS
- New biosensors and markers as well as novel tools to manage the information
- Improved storage systems
- Nanomaterials for increased biosensor sensitivity and faster detection
- New materials compatible with monitoring systems
- Easy-to-use Web applications to gather more information about patient’s
opinion (with self-evaluation questionnaires of the footwear)
- A knowledge-based software tool for the prescription of the footwear
CHALLENGES 1. To carry out more clinical research studies on the behavior of the different
foot areas in order to use appropriate materials aimed at reducing the pressure
in the foot.
2. To collect and process data from different sources to advise the clinician in
how to develop an appropriate prescription, including patient’s daily activity
profiles

RETAIL:
- Brand: design, specification and source.
KEY ENABLERS Universities, Research Centres, footwear related companies
Research Priority
RP3.5
New production technologies for the integration of new materials
SHORT DESCRIPTION Manufacturing conditions should assure that functional properties of the
materials remain unchanged during the whole process, including aspects related
to cross contaminations. For example, nanomaterials are intended to improve
the performance of existing footwear and related components production
technologies, and to give new functionalities to footwear, such as lightweight,
enhanced comfort properties and improved biomechanical behaviour, high
performance, etc. However, such new nanomaterials need to be introduced into
production and the correct controlled conditions need to be created and
maintained in industrial processes.
Main industry innovations or developments related to this research trend are
the development and demonstration in operational environments; the
integration of technologies and processing for using novel nanomaterials in
footwear production; to improve the control and monitoring of the conditions
required for the use of nanomaterials in industrial processes; to optimize and
evaluate the increased performances of the production lines in terms of
productivity and cost-effectiveness and to assess the functionality and
performance of the produced component/product.
RELATED INNOVATION - Guidelines and training on how to use the novel materials or manage the new
processes
- Development of advanced manufacturing tools (to preserve stability and retain
properties)
- Adaptation to new footwear manufacturing processes
- Development of a certification label
CHALLENGES 5. To change the mindset towards the use of the new materials and
technologies, especially in the north-African countries.
comfort and help to prevent foot pathologies.
9. Higher standardisation in the manufacturing, design and testing processes.
10. To assure that the functional properties of the new or existing materials
remain unchanged during the manufacturing process.
RETAIL:
- Brand: design, specification and source.
KEY ENABLERS Footwear companies, Research Centres, Clinicians

better integrate the actors by mean of the development of the priorities.
5.4 Up-skill providers
Training and education play an important role in
the footcare sector because it is important to
consider the need of integration among
healthcare professionals, manufacturers and
patient education on healthy footwear. One of the
unresolved matters when speaking about
education and training within the footwear sector
is in the use of the new technologies and the
sharing of information and knowledge at the
different steps of the patient journey. This is
important in the EU-MED area which is
characterized by a different footcare environment and where the transfer of knowledge from one country
to another can be a way to improve the performance in all the countries.
5.4.1 Challenges
The most important challenges which have been report for this area have been grouped in 5 typologies:
 Methodological challenges which cover the need to change and apply innovative methodologies for
training and education. This includes:

1. Need of training courses based on the contents of actual work and a training focused on the
contextualization of workers knowledge to the specific situation. Workers along the patient
journey should be supported in the formalization of their work situations, as a way to manage
the real needs arriving from the market.
2. To support the creation of know-how, by strengthening the ability to adapt the work to
uncertainty, unpredictability, and variability of real work situations. This is particularly
important to support trainees in crucial situations, and not only on simple tasks to give an
overall view to the full working situation to any category.
3. To enhance the role of the footwear companies, clinics etc. as a place of training and not just
as “consumer” of knowledge. It is important to consider companies as places where
knowledge is generated and used, and for this reason it is important to implement mechanisms
to control both the processes.
 Clinician challenges which are specific for the clinic actors in the value chain:
1. To improve capability of analyzing learning needs.
2. To transfer technology developments into practice: integration of technology advances into
daily service (for example diabetic patients). Straightforward tools and effective training to
collect biomechanical data (usually difficulties in interpreting information relating to customer
needs gathered from equipment) and implement this into following aspects of process.
3. To train actors for effective modification to footwear at fitting stage to accommodate short-
term differences in patient size or morphology. This will improve the fitting process that does
not currently consistently provide objective data to feedback into the design/specification
stage of the patient journey.
4. To support training for objective measures for individual patients to measure the success of
treatment outcomes (that are not widely integrated) and to fill the lack of education/training in
terms of their implementation or use of the data obtained. To train actors to manage patient
expectation and clinical visit at earlier stages, and also to manage effectively the patient
motivation/expectation/opinion, for success of both the fitting session and the footwear long-
term. Moreover, to avoid that decisions are reliant only on subjective/ anecdotal decisions
without objective criterion, accessible and applied training on footwear components are
required (especially for clinicians).
5. The design and training to implement measurable outcomes for the success of specific
footwear interventions for population groups. Moreover, outcome measures for footwear
tend to be holistic for the service e.g. amputation rates and thus it is hard to identify the
real/individual impact of footwear on outcomes.
 Manufacture challenges which are specific for the production of the footwear:

1. To create the same background (high quality integrated training programs) for orthopaedic
footwear manufacturers and footcare professionals, that work within different categories.
Additionally, to attract new students seeking better skills, jobs and salaries, with study/training
programs more focused on the most advanced technologies.
2. To have new competences in 3D footwear CAD for orthopaedic shoes. The diffusion of CAD
also in orthopaedic sector is important to increase capability of companies to make quicker and
more precise the design process. This is part of the more general challenge which is linked to
the need of having new training programs adapted to the new advances in footwear design,
manufacturing, and other technologies.
3. To identify foot health education needs per each group of patients and for each country and
eliminate differences in the curricula and contents of training across countries (easier
international mobility). This challenge is linked to the need of manufacturers to better
knowtheir market and to map the customers especially in cases of specific target groups.
4. To constantly update trainers as technologies evolve at great speed not only on a technical
level but also from a more creative perspective.
5. To provide effective training to retail footwear technologists/designers relating to anatomy,
specific population’s morphology and footwear requirements. In fact, the retail footwear sector
might not support this as well as clinical route due to a lack of help to buy e.g. a lack of trained
individuals to fit footwear adequately in retail both generally and specifically for populations, a
lack or stock and a lack of understanding.
6. To fill the lack in understanding of the importance of footwear features and materials for
specific populations in the retail footwear sector.
7. To support retailers during the end stage and enable patients to drive assessments and designs
e.g. online shoe fitting (rewards systems to incentivize the patients collaboration in expressing
opinions on the products), with digital solutions. To educate user in order to be responsible for
their own fit of their footwear; health promotion materials and information as to the

importance of fit and footwear features and materials which are most suitable to meet their
requirements. In some cases the challenge is even to remove retailers from end stage and
enable patients to drive assessments and designs e.g. online shoe fitting, with digital solutions
 Patient education challenges which aim to define better the needs from patients and more generally
customers:
1. Health promotion for the importance of fit and also information to make the decision as to
whether to visit a clinic or retail. Consequently, also the patient education to develop realistic
expectations for footwear that will be produced and anticipated fit and modifications.
2. Management of expectations of footwear appearance and fit, self-assessment of footwear
outcomes such as foot examination etc.
3. Patients should be trained, convinced, motivated and supported to actively participate in
their treatment; patients and other family members need to acquire knowledge, skills and
competences in relation to their illness and its effect on their foot health. In particular, to train
taking into consideration different profiles: children, young people, adults and pregnant
women and different learning levels and general culture.
 Clinical versus manufacture challenge which is linked to the need to better integrated two steps of the
overall footcare flow:
1. Difficult to implement a “dictionary” which acts as the definitive terminology for all actors
within one process to define components and features of footwear. Create a mutual
understanding (between clinicians and manufacturers) through workshops in clinical
environments. Moreover, there are difficulties within communication between clinician,
technician and manufacturer, due to differing background education, knowledge and language
used.
Research Priority
RP4.1
Methodologies for collection and formalization of training needs along
the footcare value chain
SHORT DESCRIPTION This research priority relates to the definition of a methodology for the
formalization of the training needs of all actors in the footcare chain (clinicians,
orthopaedic technicians, footwear producers, retailers, patients). The aim of the
methodology is to better define the content necessary for a better integration
and collaboration between the different categories of actors. Beside specific
training needs for each category, it is more important to work on the training
necessary for creating a seamless flow between them.
RELATED INNOVATION - Designing the Learning-skills unit and related training modules, oriented
according to recent guidelines EQF-ECVET-Learning Outcome.
- Customization of the training and validation of experiential learning.
- Innovations/developments in terms of new questionnaires/data collection
tools and methods to collate the beliefs; innovative education materials that
include consideration of patient beliefs surrounding footwear/footcare.

- Mapping exercise that captures needs of all kinds of people involved,
particularly considering the varied roles and countries associated with this
project
- A Professional Activity Referential Framework can be made and from it a
Learning Outcome Referential.
- Development of the Training Referential which by this methodology will be
adapted to the different trainees categories.
- Put in practice the «Professional Didactic» methodology which consists of the
analysis of the prescribed task, the redefined task, the effective task and the
real task.
CHALLENGES Methodological:
1. Need of training courses based on the contents of actual work…
2. To support the creation of know-how, by strengthening the ability to adapt
the work to uncertainty, unpredictability, and variability of real work
situations…
3. To enhance the role of the footwear companies, clinics etc. as a place of
training and not just as “consumer” of knowledge…
Clinician:
3. To train actors for effective modification to footwear at fitting stage
5. The design and training to implement measurable outcomes for the success
of specific footwear interventions for population groups.
Manufacture:
3. To identify foot health education needs per each group of patients and for
each country.
6. To fill the lack in understanding of the importance of footwear features and
materials for specific populations in the retail footwear sector.
7. To support retailers during the end stage, to educate user in order to be
responsible for their own fit of their footwear, to remove retailers from end
stage and enable patients to drive assessments and designs.
Patient Education:
1. Health promotion for the importance of fit and also information to make the
decision; the patient education to develop realistic expectations for footwear
that will be produced.
2. Management of expectations of footwear appearance and fit, self-
assessment of footwear outcomes such as foot examination etc.
3. Patients should be trained, convinced, motivated and supported to actively
participate in their treatment.
Clinical versus manufacture:
1. Difficult to implement a “dictionary” which acts as the definitive terminology
for all actors within one process to define components and features of
footwear. Moreover, there is difficulty in communication between clinician,
technician and manufacturer.
PATIENT JOURNEY All stages of the patient journey
KEY ENABLERS Training centers, associations representing each category

Research Priority
RP4.2
Integrated training programs for increasing the integration among
orthopaedic footcare professionals
SHORT DESCRIPTION Given the training needs, it is important to define the content and the
programmes for training of the different categories. Innovative programmes
need to support the integration between the actors so that each one knows
better which the needs of the downstream actors are.
RELATED INNOVATION - Training programs and materials for orthopaedic manufacturers not specially
oriented just to design subjects, but also to materials and production.
- Develop 3D prescription tools, to develop new orthopaedic footwear/insole
production software
- Ensuring a continuous match-up between the CAD available and the training
available
- Remove the difficulty in communication between clinician, technician and
manufacturer: due to differing background education, knowledge and language
used
- Create the same background (high quality integrated training programs) for
orthopaedic footwear manufacturers and footcare professionals, which come
from different categories.
1. Need of training courses based on the contents of actual work.
the work to uncertainty, unpredictability, and variability of real work situations.
training and not just as “consumer” of knowledge.
Clinician:
2. To transfer technology developments into practice: integration of technology
advances into daily service.
3. To train actors for effective modification to footwear at fitting stage.
4. To support training for objective measures for individual patients to measure
the success of treatment outcomes.
5. The design and training to implement measurable outcomes for the success
of specific footwear interventions for population groups.
Manufacture:
1. To create the same background (high quality integrated training programs)
for orthopaedic footwear manufacturers and footcare professionals, that come
5. To provide effective training to retail footwear technologists/designers.
6. To fill the lack in understanding of the importance of footwear features and
materials for specific populations in the retail footwear sector.
KEY ENABLERS Training centers and associations representing each category

Research Priority
RP4.3
New ICT based courses for footcare professionals to integrate the
footcare chain
SHORT DESCRIPTION According to the specific programmes necessary for the integration of the
footcare categories, it is important to develop ICT-based tools allowing the
proper management of the content.
The aim of the research priority can be to develop a multi-level web service
enabling the actors of the orthopaedic sector to receive personalised training in
an innovative and continuous way. The tools can support acquisition of
information, of procedures as well can support decision making process.
According to the footcare category, and to the content to delivery tools to be
developed can be APPs, open source platforms, e-learning programmes, virtual
reality for training on procedures, game-based tools for gathering information
on the products, etc.
RELATED INNOVATION - Develop technical courses based on new ICT for professional foot care
(podiatrists, clinicians...)
- Develop 3D prescription tools, to develop new orthopaedic footwear/insole
production software
- Continuous match-up between the CAD available and the training available
- Capture and record of the morphology and loading forces of the foot in stance
and swing in perspective of: the design of a shoe-aid orthopaedic and the
definition of technical specifications
- Innovations and advances in 3D scanners and also manufacturing technologies
(robotics), existing developments of INGA 3d project, development of online
course of Computer Aided Design for Footwear.
- New training content and supportive e-learning tools based on units of
learning outcomes and competencies.
- Development of online course of Computer Aided Design for Footwear.
- Supportive e-learning tools based on units of learning outcomes and
competencies.
- INGA3D project and related outcomes would be innovation/developments
related to this technology area and trainee.
1. Need of training courses based on the contents of actual work
the work to uncertainty, unpredictability, and variability of real work
situations…
training and not just as “consumers” of knowledge.
Clinician:
4. To support training for objective measures for individual patients.
Manufacture:
1. To create the same background (high quality integrated training programs)
for orthopaedic footwear manufacturers and footcare professionals, that come
2. To have new competences in 3D footwear CAD for orthopaedic shoes.
4. To constantly update trainers as technologies evolve at great speed not only
on a technical level but also on a more creative.

7. To support retailers during the end stage, to educate user in order to be
responsible for their own fit of their footwear, to remove retailers from end
stage and enable patients to drive assessments and designs.
KEY ENABLERS Training centres, associations representing each category, software providers
better integrate the actors by mean of the development of the three priorities for the training and
education.

5.5 End-user driven
End-users within the footcare and footwear sector can be considered as both patients in a clinical setting
(or route) and consumers, or customers, in a retail setting. The requirements of the end-user should drive
the footcare sector to ensure that their needs are met with the technologies, products, guidelines and
services which are provided.
These can be in terms of physical needs (e.g.
footwear which comfortably fits their foot),
emotional needs (e.g. footwear is aesthetically
pleasing) and access needs (e.g. footwear is
available in high-street retailers). These needs
are specific to the user and vary across the
population groups (adults with Diabetes, or who
are obese or elderly) and across regions (North
Africa and Europe). Such needs may vary
dependent on the severity of the users foot
health issue, their socio-economic status and the
environment in which they live. Ensuring that the
needs of end-users are met will increase adherence, satisfaction and functioning of footwear or orthotics
and means that the sector is fit for purpose. Therefore, this working group was created, within the
SoHealthy project, to ensure these user-driven requirements are addressed.
5.5.1 Challenges
The key challenges identified relating to end-user driven aspects of the patient journey in the healthcare
route are:
1. Lack of patient sensation of involvement, choice, understanding and empowerment in the process.
If the patient does not feel like they are involved in the processes and decisions their sense of satisfaction
as well as their adherence to behaviours and devices is lower. If patients are involved in decisions they are
more likely to be content with the intervention they are provided, to use it more often and thus there is an
improvement in clinical outcomes. Dissatisfied patients may miss follow-up appointments, not use the
devices prescribed and ignore advice relating to behaviour. This means that there issue remains
unmanaged or unresolved and is more likely to increase in severity, reducing their health and increasing
their demand on the healthcare system later.
2. Conflict between patient and clinician outcomes, requirements and expectations.
The patient may have specific requirements in terms of expectations relating to the footwear or footcare
they receive. This may be a desire for a certain appearance, cost, style or material, which actually is not
suitable for their foot condition or clinical status. Therefore, the aims of the clinician directly conflict with
that of the user. It may be that some of this challenge results due to it being hard for the user to visualise
the final product; they can be guided to some extent by the knowledge and experience of the clinical and
by their own previous experiences of receiving footwear/orthoses – although these may well be negative
experiences and will serve to influence any future choices the patient may make.

3. Lack of standardised protocols, objective data and clinical guidelines
The therapeutic approach to the patient is currently dependent on the subjective judgement of the clinician
with little input of objective factors combined with specific, detailed clinical guidelines. Such guidelines
would require to be population/condition and region specific in order to ensure the most relevant and
effective care for individuals specific to their clinical, societal and environmental situation. Automatic
knowledge based decision systems could generate therapeutic decisions such as the most appropriate
material for a known condition etc. and remove subjective decisions from such footwear design processes.
4. Time available to patients to attend the clinic and the time for clinicians to conduct assessments.
Time is a definite challenge for all aspects of assessment (both from a patient and practitioner perspective-
time spent in consultation and time to attend the consultation – especially if the patient is still working).
Patients may also be less reluctant to make time in their diary if they do not understand the importance of
maintaining their foot health and/or agree with the decisions clinicians are making. Reducing the time
required in the clinic for the patient may be beneficial in terms of demanding less from their diary and also
means there is more time for more patients, however this may seem the appointment seem less valuable.
An increased availability of clinicians would enable more appointments to be available to patients who
require them.
5. Lack of specific outcome measures, which are valid to actual use of footwear/footcare.
Currently it is not widespread to measure the patient outcomes of a prescription in terms of satisfaction or
hours worn. Outcomes to be measured should be user defined as well as clinically relevant and should be
valid to define the use of the footwear/footcare device prescribed or purchased. This could include
subjective questionnaires to quantify satisfaction as well as integrated portable devices which quantify
hours worn. However, these need to reflect cultural and geographical variances between the defined
populations of diabetes, aging and obese individuals. Such outcome measures should produce data which
can be integrated into improvements of services for specific patients and conditions in an objective
manner.
6. Difficulty integrating data into order processing and manufacturing process.
The integration of user specific data automatically in the ordering and manufacturing processes for
therapeutic footwear represents a challenge. There are difficulties with terminology utilised between
different sectors not being consistent such as podiatrists and footwear designers. This means that there are
opportunities for errors within the supply chain. The seamless integration of order processing to
manufacture would reduce the human intervention and involvement in this process. This would connect
clinician specification, patient personalisation, supplier material/component availability and manufacturer
constrains, reducing the opportunities for errors within the supply chain.
7. High human involvement in manufacturing process.
The current process for the prescription, manufacture and provision of orthopaedic footwear is highly
reliant on human involvement. This makes the process more exposed to human error and also more time
consuming. For example, automatic inspection (without direct human intervention) of the final product,
looking not only for quality defects, but also assuring the compliance of final product with the

individualized design document (including the patient biometric data and health related information) offers
opportunities for quicker and more accurate processes.
The key challenges identified relating to end-user driven aspects of the patient journey in the retail route
are:
8. Lack of information to users to select the correct footwear (style or fit) to meet their requirements
(lack of clinical education/experience, patient education, brand/manufacturer advice and retail being
a business).
The brand needs to be able to clearly define the needs of the users as their target audience in order to
attract them as a purchaser. The retail brand has to develop an in depth understanding of what is required
by the person with a specific clinical condition in terms of physical and emotional requirements. Once a
brand has established a specific range for a specific user they need to be able to communicate this to the
wearer. This requires a coherent, believable and widespread message to potential users as to the suitability
of this footwear to meet their specific needs. Patient groups and the government also have a role in this
process in terms of education for patients/users informing them of the risks of ill-fitting or unsuitable
footwear, particularly for higher-risk feet.
9. Footwear styles are not available through retail, which accommodate the users multi-factorial needs
in terms of appearance, fit, cost, materials, clinical recommendations etc.
There currently lacks widely available retail footwear for specific population groups, this is evident by many
brands or manufacturers not producing wide-fit or half size shoes. Some shoes which represent more
suitability for users in terms of wider-fit, more flexible leather and adjustable openings may be more
expensive and therefore not meet the needs of wearers in terms of affordability. Most footwear which is
defined for specific users is also not aesthetically pleasing and therefore does not meet the users’ needs
from an emotional perspective. The outcomes and how they are measured in the retail sector must be
defined with the direct collaboration of the individual populations and be particular to the relevant
stakeholder countries or broad geographical location and environments.
Research Priority
RP5.1
Methodologies for foot health education needs per each group of
patients and country
SHORT DESCRIPTION This is the highest priority and an over-arching concept from the working group
considering footcare and footwear provision being user driven. It is country,
region and patient specific and defining these needs specifically impacts on the
advice that is required by the patient in addition to the format and source of
such advice. Aspects of foot health education needs for consideration include:
- Decision: Education for patients to make the correct decision relating to
whether to attend clinic or retail for their footwear.
- Knowledge of footwear sector: Education relating to roles in the footwear
sector.
- Real expectations, use of data etc.: Education relating to what their
requirements from footwear influencing design etc., what information they will
need to provide and how this will be used etc.
- Footwear fitting/trying/sizing information: Education relating to making fit

judgements, which tools to utilise for this information and the limitations of
fitting and shoe sizing information.
RELATED INNOVATION - Qualitative long term outcome tools
- Sensor technology for in-shoe measurement
- Patient centred (social, cultural and physical) training and education tools
- Specific testing and kite-marking.
CHALLENGES 1. Lack of patient sensation of involvement, choice, understanding and
empowerment in the process.
8. Lack of information to users to select the correct footwear (style or fit) to
meet their requirements (lack of clinical education/experience, patient
education, brand/manufacturer advice and retail being a business).
9. Footwear styles are not available through retail, which accommodate the
users multi-factorial needs in terms of appearance, fit, cost, materials, clinical
recommendations etc.
PATIENT JOURNEY Decision at start and end of process.
HEALTHCARE & RETAIL: Outcome
KEY ENABLERS National, regional and local associations (Diabetes UK); forums and social
networks; hospitals and health services; technical institutes (INESCOP),
academics and research centres; marketing from manufacturers.
Research Priority
RP5.2
Methodologies to meet the emotional needs of users through co-
design technologies, material and training provision
SHORT DESCRIPTION This priority combines various technology areas, however reflects a more user-
driven approach in terms of enabling co-design with users to better meet their
style requirements thus improving their satisfaction, involvement and
adherence. Technologies relating to advanced tools, education for designers,
improved and more accessible CAD options, wider availability of materials and
patient and user education to inform them of such a tool and its availability
would all combine to meet this aim and priority.
RELATED INNOVATION - Advanced and CAD tools for personalisation of products and co-design.
- Training for designers in material and design requirements with specificity to
patients.

2. Conflict between patient and clinician outcomes, requirements and
expectations.
HEALTHCARE: Agreed design/specification, Decision, Outcome
RETAIL: Design, Specification, User Opinion, Retailer Opinion, Outcome
KEY ENABLERS Companies using co-design (e.g. Allyourcolours, Shoes of Prey); CAD software
developers; retailers and brands; training and education providers.
Research Priority
RP5.3
Sensors embedded in orthotics/ footwear to measure forces and
pressure for patient feedback and to asses function
SHORT DESCRIPTION The functioning of devices is important for the understanding of clinicians and
researchers and also to feedback knowledge into the provision to ensure this is
appropriate. Sensors also play an important role in educating users, involving
them in the provision process and patient journey and thus improving their
sensation of engagement and value. In retail such devices may act as a tool at
point of sale to convey a scientific message from brands or manufacturers to the
user.
RELATED INNOVATION - Senor, measurement and analysis technologies to make data collection less
intrusive.
- Clinical trials thoroughly defining end- users and resulting clinician training and
patient education.
- Wearable technologies to make data collection less intrusive.
3. Lack of standardised protocols, objective data and clinical guidelines
4. Time available to patients to attend the clinic and the time for clinicians to
conduct assessments.
Clinic: Agreed design/specification
Manufacture: Specification/design
RETAIL:
Brand: Design
KEY ENABLERS Orthotic and footwear researchers; organisations that produce patient
applications and feedback tools; clinicians.

Research Priority
RP5.4
New supportive tools, applications and solutions for e-learning to aide
patient adherence
SHORT DESCRIPTION Aiding and increasing patient adherence to devices is essential to ensure that
the technology and product advances actually result in improvements in patient
outcomes. If adherence remains low then advancements in product technology
lack impact. Engagement with the patient through e-learning and supportive
tools increases their sense of engagement with the process.
RELATED INNOVATION - Marketing and publicity innovations in retail.
- Tools and patient education to better direct patients to suitable footwear in
retail or clinic.
- Advances in trials and patient definition.
2. Conflict between patient and clinician outcomes, requirements and
expectations.
4. Time available to patients to attend the clinic and the time for clinicians to
conduct assessments.
HEALTHCARE & RETAIL: Outcome
KEY ENABLERS Education providers; Patient groups and associations; Forums; health services;
organisations that produce patient feedback tools.

better integrate the actors by mean of the development of the three priorities for the training and
education.

5.6 Cross-cutting issues
The research priorities may cover one or more research areas and maybe linked to other research priorities
defined by the other working groups. The understanding of the relationships between the research areas
can help us to create synergies between them and better define the research projects that may arise from
these research lines.
The relationships between the research lines defined in each working group can be seen in the following
tables:
WG1: TOWARDS MORE EFFICIENT PROVISION
Research
priority
Links Reason for linking
RP1.1 RP2.2a,
RP2.2b,
RP2.3a,
RP2.3b, RP3.1,
RP3.2 & RP3.4
A 3D prescription tool should display the range of materials available,
including those new materials and textiles for health care applications. In
addition, this prescription tool should have information about the
biomechanical behaviour of the materials as well as many other relevant
pieces of information from footwear/footwear components made of
materials embedded within the tool. The prescription tool could be
connected with a pressure visualisation software that manages pressure
and temperature information.
RP1.2 RP2.3a A new generation of 3D/4D scanners, which are cheaper and really portable,
should provide relevant information such as information about pressure
and temperature and therefore should be linked with a pressure
visualisation software that additionally manages that information and
assists in the integration of the resulting information in a prescription or
design.
RP1.3 RP2.3a, RP3.2,
RP3.5 & RP4.3
The new and/or improved CAD/CAM tools for the manufacturing of custom
therapeutic footwear and insoles should take into consideration the
information generated from the prescription phase as well as the features
and behaviour of the new materials developed. For the use of these new
tools, the development of new ICT based courses for footcare professionals
would be required.
RP1.4 RP2.2a,
RP2.2b, RP3.1
& RP3.5
For a higher use of AM it a wider range of materials is required. Those
materials should be suitable for health care application. The introduction of
robots in the production lines is related to the development of new
production technologies.
RP1.5 RP2.2a,
RP2.2b, RP2.3b
RP3.1, RP3.2,
RP3.3 & RP3.5
After the development of new materials these ones should penetrate into
the market, where the suppliers play a crucial role, producing them and
ensuring a right provision. This supposes the development of new
production technologies as well as new testing methods to evaluate the
materials’ new functionalities.
RP1.6 RP3.2 & RP4.3 In order to test the orthopaedic shoe/ shoe component before its
manufacturing the biomechanical behaviour of the shoe and the materials
of which it is made needs to be defined. In order to make this information
integrated and useful, it would be necessary to develop new training
courses.

Figure 33: Relationships between research priorities – WG1
WG2. TOWARDS REDUCED FOOT INFECTION
Research
priority
RP2.2(1) &
RP2.2(2)
RP3.1 & RP3.4 The development of new materials used in footwear will help reducing and
preventing foot infection of diabetic, obese and old foot by monitoring
parameters (temperature, humidity, etc.)
RP2.5 RP5.1, RP5.4 &
RP4.1
Patient awareness and education are essential to help them to care for their
feet and provide tips to prevent serious foot problems.
RP2.4 RP5.2 Standardised guidelines for appropriate footwear for SoHealthy target
would ensure better suitability of footwear.

WG3. TOWARDS MATERIALS INNOVATION
Research
priority
RP3.1 RP2.2a &
RP2.2b
The development of new smart materials for health care applications
includes those with antimicrobial properties.
RP3.2 RP1.1 & RP1.6 The knowledge related to the biomechanical behaviour of the materials
would be used by 3D prescription tools as well as a virtual shoe test bed.
RP3.3 RP1.5 A novel organisational model should take into consideration the new testing
methods to evaluate the materials’ new functionalities.
RP3.4 RP2.3a,
RP2.3b, RP4.3
& RP5.3
The development of new materials as diagnosis tools would involve smart
materials with sensors to monitor some relevant parameters (temperature,
humidity, etc.). Data extracted from these sensors would have to be
processed by an innovative pressure visualization software. To manage this
software, it would be needed to develop ICT based courses.
RP3.5 RP1.4 & RP1.5 A novel organisational model should take into consideration the new
production technologies related to the integration of new materials into the
production lines as well as the introduction of robots and AM techniques in
such production lines.

WG4. UP-SKILL PROVIDERS
Research
priority
RP4.1 RP5.1 Education needs are to be identified along the value chain from clinicians to
patients. The application of a shared methodology can have the advantage
to have a common standard definition of the needs which can be used
across- the patient journey, i.e. in educating the clinician could be useful to
know which are the education needs of the patients to teach the clinician
also what the patient needs is.
RP4.3 R5.4 To develop e-learning solutions which are customizable for any category of
actor in the patient journey
WG5. END-USER DRIVEN
Research
priority
RP5.2 RP2.2, RP3.2 &
RP3.5
The development of materials and responsive materials and assistance with
material selections provides the potential opportunity for development in
footwear designs. Such designs may be better able to incorporate the users
emotional and physical requirements.
RP5.4 &
RP5.1
Rp2.3 (2) The development of smart textiles for monitoring patients provides the
opportunity for integration of the outcomes and variables within patient
tools for e-learning. This could be apps or solutions, which demonstrate the
foot is at risk from temperature for example, priding the user with
information to manage and change their behaviour and aid appropriate
adherence to devices.
RP5.2 RP2.4 & RP3.3 Standardised guidelines for appropriate footwear for high the risk foot and
other patients would complement new, novel testing methods to assure fit
for purpose. These priorities and outcomes would likely ensure better
suitability of footwear/insoles for specific users in terms of aesthetic and
functional demands.

RP5.4 &
RP5.1
RP2.5 Supportive tools, applications and solutions for user education and
adherence would provide patients with information to manage their
condition alongside any footwear interventions. This could include specific
approaches to patient education for management of their high risk foot and
adherence to prescribed treatments. This approach first requires the
identification of the foot health education needs of the wide range of
patients and consumers.

6 Recommendations & Needed Initiatives
Since the SoHealthy project started in 2013, a series of exchange visits and events were carried out in
Morocco, Italy, United Kingdom, Spain and Tunisia, with the aim of being aware of the footcare sector’s
situation across Europe and MENA. Thus, podiatry units in hospitals (such as Hope Hospital (United
Kingdom), the Centre Hospitalier Noor (Morocco), and Institut National d'Orthopédie Mohamed Kassab
(Tunisia)), orthopaedic footwear companies (such as Calzolaio Antonio Rigato and Alma Ortopedica (both
Italy)), orthopaedic centres (such as the Centre National d’Appareillage Orthopédique (Tunisia)), as well as
private podiatry clinics (such as Instituto Valenciano del Pie (Spain), the Podiatry clinic facilities of the
University of Salford (United Kingdom) and the private clinic of Ms. Hind Benziane, President of the
Scientific Moroccan Association of Podiatrists ( Morocco)) were visited in these countries. Similarly, a
number of seminars and validation workshops were organised during the project, where relevant experts of
the footcare sector gathered together to discuss the research trends arising from the current and future
situation of the footcare sector. Therefore, this section contains some of the conclusions and
recommendations extracted and learnt from the experiences during these exchange visits and seminars
and the discussion with the diverse professionals working within the organisations visited.
6.1 Italy
In Italy we can find podiatry clinics that also manufactures the orthopaedic footwear, so that they are in
close contact with the patients throughout the whole process. Thus, it is not strange to see that these
clinics/companies think that the aesthetical appearance of the orthopaedic shoes is very important and
therefore the design is something that it is worth reinforcing. However, as it is observed in other European
countries, the production process is characterized by a strong handmade component, hardly automated.
Despite they know that currently there are some technologies on the market that enable the automation of
some processes, i.e. foot/last digitizers, specific software for the designing of the footwear, etc., these
technologies are perceived as very expensive and some manufacturers even wrongly think that automated
processes take more time than using the traditional processes. Therefore, once again, the industry should
better transmit these technologies’ advantages to the health professionals and companies or/and there
should be a better communication flow between them.
One of the main concern in this industry, worldwide, is the delivery date of a pair of customised
orthopaedic shoes, due to the number of trials that are needed until obtaining a final model. This makes
the product much more expensive, so the reduction in the delivery time would be very important for the
industry and the patient, who has to pay them.
The different professionals and experts interviewed agreed on that the health insurance in Italy should
reduce bureaucracy and it is very important that all representatives from the value chain work together. In
addition, more support is needed from the government and all interested parties should work in the
standardisation of data in order to access global markets. The integration of the technologies to provide a
global solution is also important because now there are different technologies available but they do not
know how to integrate them. They are also worried about the situation today in the sector, because due to
the crisis, clinicians are prescribing standard shoes instead of custom made shoes, which are much more

expensive. Therefore, it is needed a higher coverage of this kind of footwear by the Italian National Health
System.
Other relevant recommendations are:
 Creation of a glossary for all the actors of the footcare value chain, to ease the communication
 To reinforce the relationship between footcare and footwear supply chain to reduce mistakes during
production
 Updating of the official social health pricing system for footwear orthosis
 Standardized method for foot measurement
 To improve the provision of footwear suitable for specific population groups, especially diabetics,
elderly and obese, through well-designed and fitted retail footwear
6.2 Morocco
Despite that more than 2 million people in Morocco suffer from diabetes and more than 10 million people
are obese or overweight, in Morocco there are only 20 podiatrists. Therefore, a high percentage of
diabetics will develop diabetic foot syndrome and these people will not be correctly treated, what it will
lead to the development of foot ulcers, foot amputations and finally deaths. These podiatrists have
followed their studies in other countries, as there is no specific training on podiatry in Morocco, and there
are no podiatry units in local Hospitals involving specialised professionals.
In addition, the Moroccan health system does not cover the cost of orthopaedic shoes, which are too
expensive for the 90% of population, and it partially covers the cost of the insoles, depending on each
patient’s insurance coverage. Therefore, it is considered also necessary to undertake some important
measures that lead to a better treatment and prevention of the diabetic foot syndrome as well as other
foot conditions. Some of these measures would include the development of a university degree in podiatry
in order to train new podiatrists, the creation of specific podiatry units in hospitals, patient education
through the development of a higher number of awareness campaigns and a higher financial support from
the Ministry of Health and the Government so that orthopaedic shoes and the related components are fully
or partially covered by the health system.
 To build universities and centers for footcare training and courses.
 To provide training to healthcare professionals relating to how to deal with diabetic foot.
 To include pedorthic education in Morocco.
 Engage and develop strong relationship between policy makers and footcare chain.
 Provide therapeutic education for people with diabetes elderly and obese.

 To reinforce the relationship between footcare and footwear supply chain.
 To include podiatry in the public health system.
 To include national social security fund reimbursement for orthopaedic shoe.
 To integrate footcare into government strategic policies.
6.3 Spain
In Spain, some private podiatry clinics use CAD/CAM tools for designing customised footwear and insoles
from the patients’ foot measures obtained by means of different ways: foot measures taken manually,
measures obtained with Microscribe, digitised feet, digitised moulding foam or digitised footbeds/lasts.
However, despite current big advances in Software tools, there still remains much to be done. For example,
the majority of the private podiatry clinics, even the public podiatry units or diabetic foot units at hospitals,
normally does not use these software tools. Therefore there should be a higher support from the Spanish
government in the introduction of these new technologies in public hospitals or, instead, there should be a
higher and better flow of information between the industry and the public health professionals.
 To implement clinical and preventive intervention programs with effective prevention measures that
lead to a reduction of the T2DM’s risk factors. Related to this, it is necessary to implement agreed
protocols of treatment, at a national level, in order to reduce the chronic diabetes complications and
the high costs related to these.
 To include podiatrists in the Spanish public health system to provide preventive foot care: diabetes,
obesity and ageing have consequences on patient’s feet health that need of specialized podiatric
care. Therefore, the Spanish population should been able to have access to a multidisciplinary team,
within the Spanish health system, where the role of the podiatrist should be included. Among these
podiatrists’ duties there would be not only preventive tasks (primary care), but also specialized care
of the problems related to these diseases (secondary care) and their chronic complications.
 To facilitate a high patient involvement for a better understanding of the disease and therefore, a
better control and an effective self-management of the disease. This would also provide relevant
and useful information from patients to improve quality treatment and health management system.
 To implement cost-effective measures to reduce the burden of diabetes disease and in parallel, to
develop a method of measuring cost-effectiveness.
 To include within the diabetes plans of each autonomous community the creation of more
multidisciplinary clinics for holistic management of the diabetic foot complications.
 The footcare industry should design and manufacture more stylish therapeutic footwear, offering a
higher range of models/styles, colors, materials, etc. in order that podiatrists can reach their
therapeutic goals as a result of a higher patient’s adherence to the treatment.

 According to the podiatrists’ opinion, the footcare industry should count on the advice of podiatrists
for designing and manufacturing therapeutic footwear/footwear components in order to know
more about patient’s needs so that the desired requirements are met.
 To improve diabetic foot care by creating more multidisciplinary diabetic foot units (DFU) in Spain
and improving the full development of the existing ones. These DFU should include podiatrists.
 To provide a higher and more realistic financial coverage of orthopaedic shoes’ costs. The Spanish
National Health System should also cover the cost of orthopaedic insoles. These costs should be
based on real data, taken from the footcare industry.
 Less diversification in the diabetic foot treatment in Spain, with a higher standardization among
autonomous communities.
6.4 Tunisia
Unlike other North African countries, the CNAM, the Tunisie Nouveau régime d'assurance maladie (the
Tunisian public social Security system), covers the total cost of a pair of orthopaedic shoes and insoles, but
unfortunately the waiting list is of 6 months approx., which is definitely too long for a patient who has
diabetic foot. In addition, the CNAM only covers 1 pair of orthopaedic shoes per 1 year for adults, what it is,
in most cases, insufficient. Therefore it is necessary to get more funds and resources (human resources,
more infrastructures, materials, etc) to supply the demand.
In Tunisia, the process of manufacturing the different orthotic devices, orthopaedic footwear and insoles is
very handmade and therefore, the use of new technologies is low. However they use CAD/CAM software
for designing the insoles. The materials they use for the insoles are the same as used in other countries,
with very slight differences, for example, due to the weather, they prefer to use leather instead of other
materials.
Tunisian foot health professionals interviewed in the framework of the SoHealthy project think that the
prevention is crucial and in Tunisia this is a huge problem as, in almost all cases, the patient goes to the
orthopaedic centre once he/she has the foot problem. As a consequence, up to 50% of people with
diabetes are undiagnosed and a high percentage of people already diagnosed do not go to the orthopaedic
centre until the foot ulcer appears. Therefore, it is necessary that the general practitioner is educated and
encourage the patients to visit the orthopaedic centre before the problem appears. It would be also
necessary to organise more awareness campaigns in order to educate the population about the importance
of visiting the podiatrist periodically once it is diagnosed. These measures should be accompanied also by
higher economic support from the Ministry of Health and the footcare industry should work on
manufacturing cheaper orthopaedic shoes/ orthotics/ insoles and in a faster way. It would be also desirable
to manufacture lighter and more fashion orthopaedic shoes.
 To strengthen clinical and preventive intervention programs with effective prevention measures that
lead to a reduction of the T2DM’s risk factors.

 To strengthen clinical and preventive intervention programs to reduce the burden of obesity.
 To develop better knowledge about preventive and curative foot care/treatment
(orthopaedic/therapeutic shoes, insoles) and how/where access to these treatments for patients.
 To set-up multidisciplinary units for holistic management of the diabetic foot complications.
 To facilitate a high patient (or care giver) involvement for a better understanding of the
complications and risks of the foot and therefore, a better control and an effective self-management
of the disease. This would also provide relevant and useful information from patients to improve
quality treatment and health management system.
 To provide a more realistic financial coverage of orthopaedic/therapeutic shoes’ costs.
 To accelerate the acquisition of specialized orthoses and therapeutic shoes in elderly and diabetes in
order to reduce the risk of loss of autonomy.
6.5 United Kingdom
In United Kingdom, as it is observed in other European countries, there is a difference between private and
public sectors in the use of the new technologies. Private clinics normally integrate and use these new
technologies first while the integration of this process is very slow in podiatry units at public hospitals, so
that they usually work following the traditional procedures, which are very manual. One of the reasons it is
because of the price, as the new technologies are perceived as very expensive, and they do not perceive
the technical advantages or the short amortization periods for the investment costs. Maybe this is caused
because the industry does not transmit well these advantages to the health professionals or/and there
should be a better communication flow between them.
The foot health professionals interviewed were asked what they would ask to the footcare industry and
they answered that they would ask to improve style aspects, a higher choice of models, improved product
finish and enhanced performance because sometimes they found that products made with high-
technologies did not show improved performance compared to manual produced products.
To highlight that the NHS covers 2 pairs of shoes and orthotics per year, and patients go to regular follow-
up visits to assess the performance. This is far different from the situation shown in other European
countries, where they receive much lower support from their governments.
 To develop a consistent approach to foot health across different regions and NHS trusts.
 To increase the time available for clinicians to assess and treat patients and therefore improve
patients perceptions of their care and the potential for effective treatments.
 To fully integrate research and clinical trials data into services, treatments, interventions and
guidelines.

 To increase the wider provision of footwear suitable for specific population groups through well-
designed and fitted retail footwear to avoid users becoming patients and thus reduce the pressure on
the healthcare system..

7 Conclusion
Industry, science and public authorities have recognised the societal challenges of conditions related to
obesity, diabetes and aging. Specifically, the demands placed on the foot health system and the ability to
meet some of these demands through integrating, improving and enabling technologies from different
sectors within the footcare sector(s).
The Sohealthy project has provided an innovative framework where all actors of the footcare value chain
could collaborate (clinicians, producers, providers, training institutions, public authorities) with the aim to
accelerate research, enhance cooperation, increase R&D investments and mobilise a critical mass of
resources throughout Europe and North African Countries. By establishing a constantly growing community
and developing a coordinated strategy, Sohealthy has identified technological breakthroughs which have
resulted in research priorities for the footcare sector. These research priorities are grounded in the need to
generate and exploit enabling technologies as well as new organizational models and training methods.
These breakthroughs need to be transformed into marketable products and services that are competitive
on world markets to support the improvement of the footcare sector. Both in terms of improving working
conditions for healthcare professionals, technicians and manufacturers in addition to improving the foot
health of patients and consumers. Given the dimension of the identified challenges it is not possible to
imagine that actors can act individually, but they need to work together thanks to the implementation of
new research and innovation projects.
These projects will lead Europe to economic growth and social sustainability for a better future. The topics
addressed by the project are cross-sectorial because they can cover by health care research as well as ICT,
manufacturing and training areas.
The information provided in section 6, related to the exchange visits and the different events carried out
throughout the SoHealthy project, has revealed that the current foot health situation in each country is
very different. Each is starting from a different knowledge, skills, research and foot health sector
infrastructure baseline, and thus moving forwards each country has needs that differ in important ways.
These add to the diversity in cultural and societal characteristics which shape how future research and
innovation actions and progress in the foot health sector will be made. This leads us to the conclusion that
specific cooperation actions are needed on a local as well as European level, taking actions in each
community and embracing the “Think globally, act locally” strategy.
To highlight; the implementation of research priorities defined within this agenda cannot be fully achieved
if there is not a suitable innovation climate. In some countries, educational levels (skills and knowledge)
are currently significant barriers to the development and diffusion of innovation in the foot health sector.
Being aware of this, first it is important to promote suitable and sustainable innovation framework
conditions, identifying those facilitators, innovators and key actors of the innovation system in each
country. This fact is specially important in the Mediterranean partners countries (Tunisia, Morocco, Egypt,
etc). These improved innovation conditions would support the implementation of the research priorities, as
well as more –and better quality- cooperation between countries.

8 Acknowledgements
The SoHealthy project team wish to express their sincere gratitude to those who have contributed to the
development of this strategic research agenda. Most especially to the members of the working groups,
without their valuable contribution and expert advice this agenda was not have been possible.
We would also like to thank the European Commission for their financial support and for believing in our
project.
We are grateful to the following contributors who have participated in the development of this agenda1
,
our apologies are extended to anybody whose name we have inadvertently omitted or misspelled:
Name and Surname Organisation Country Contribution
Arán Dr. Francisca
Head of materials department at Instituto
Tecnológico del Calzado y Conexas
(INESCOP)
Spain Working group 3
Barkaoui Ing. Amira
Engineer at the Centre National du Cuir et
de la Chaussure (CNCC)
Tunisia Working group 3
Bellotti Mr. Giuseppe
Expert in standardization and footwear
production at CIMAC
Italy
Recommendations
and situation in Italy
Benvenuti Mr. Luca
Expert in shoe design for Politecnico
Calzaturiero
Italy Working group 3
Benziane Dr. Hind
Podiatrist and president of the Scientific
Moroccan Association of Podiatrists
(AMSP)
Morocco Working groups 2 & 4
Bertazzo Dr. Marcelo
Head of the Biotechnology department at
Instituto Tecnológico del Calzado y
Conexas (INESCOP)
Camp Fauli Mr. Ángel
Podiatrist and director of a private diabetic
Foot Clinic
Spain
Working group 3,
recommendations and
situation in Spain
Chaabi Ms. Fatima Director of Podomar France
Working group 2,
recommendations and
situation in Morocco
Ceccarello Mr.
Luciano
Expert in footwear production processes
for Politecnico Calzaturiero
Davia Dr. Miguel
Researcher at Instituto Tecnológico del
Calzado y Conexas (INESCOP)
Doñate Alfaro Mr.
José
General manager of Automática & Control
Numérico, S.L.
1
In alphabetical order

Dziri Pr. Catherine
Institut National d'Orthopédie Mohamed
Kassab
El Azhar Mr. Adil
Responsible for technology projects of
footwear and leather industry in the areas
of CAD/CAM and information technology.
Morocco
Working groups 1 & 4
& 5
Figueiredo Teles Mr.
Vasco
Director of Productech, the Portuguese
Cluster of Production Technologies
Portugal Working group 1
Graham Mrs. Andrea Lecturer in Podiatry, University of Salford UK Working group 5
Hashmi Dr. Farina Lecturer in Podiatry, University of Salford UK Working group 2
Hernández Stark Mr.
Rafael
Researcher at Instituto Tecnológico del
Calzado y Conexas (INESCOP)
Hurley Mr. Colin
Healthcare Business Consultant/ University
of Salford
UK
Working groups 2 &
situation in UK
Irmani Ing. Ahlem
Laboratory Director at the Centre National
du Cuir et de la Chaussure (CNCC)
Kaba Mr. Salaheddine
Responsable of Chemical laboratory
(CMTC)
Morocco Working group 2
Kortas Mr. Elyès
Engineer at the Centre National du Cuir et
de la Chaussure (CNCC)
Tunisia Working groups 1 & 4
Leo Mr. Luigi
Calzaturiero
López Estrella Ms.
Olivia
Competitive Intelligence (INESCOP) Spain Working group 4
Lucangeli Dr. Angelo
Podiatrist and collaborator of Politecnico
Calzaturiero.
Italy
Recommendations
and situation in Italy
Mandolini Mr. Marco
Researcher at the Industrial Engineering
and Mathematical Sciences department,
Università Politecnica delle Marche
McAdam Dr. Jane
Director of Prosthetics & Orthotics and
Podiatry, University of Salford
UK Working group 4
Merino Torres Dr.
Juan Francisco
Head of the Nutrition and Endocrinology
service at the Hospital Universitari i
Politècnic La Fe (Valencia)
Spain
Recommendations
and situation in Spain
Montiel Dr. Enrique Assistant director at Inescop Spain Working group 5
Páez Moguer Pr.
Joaquín
Podiatrist and professor at the University
of Malaga
Spain
Recommendations
Paquola Dr. Chiara
Expert in training methodologies for
Politecnico Calzaturiero
Paquola Mr. Bruno
Expert in training methodologies for
Politecnico Calzaturiero
Pérez Ms. Rosana
Head of the training department at
Instituto Tecnológico del Calzado y
Conexas (INESCOP)

Petcu Mr. Daniel
Senior Researcher in Footwear Design
Department of INCDTP-ICPI
Romania Working group 5
Rigato Ing. Wladi
General manager of Calzolaio Antonio
Rigato
Sperandio Mr. Giorgio
Calzaturiero
Sraïri Dr. Fethi
Director of the “Centre d’appareillage
Orthopédique CAO”
Tunisia
Tescaro Ing. Mauro Director of Politecnico Calzaturiero Italy Working group 3 & 5
Toledo Huete Ms.
Cristina
Director of the podiatry clinic area, head of
the podiatry department at Universidad
Europea (Madrid)
Spain
Recommendations
Van Netten Dr. Jaap
Research coordinator at the ZGT (Hospital
Group Twente) and member of
International Working Group on the
Diabetic Foot
Netherlands Working groups 2 & 3
Wakkak Ms. Nazha
Responsible of physical-mechanical
laboratory testing (CMTC)
Morocco Working group 2
Williams Dr. Anita
Senior Lecturer in Podiatry, University of
Salford
UK Working group 4
Table 4: List of contributors

sohealthy Project

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