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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
3A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
2.2.2 Overweight and obese ...........................................................................................................29
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
2.4.2 Overweight and obese ...........................................................................................................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
2.5.2 Overweight and obese ...........................................................................................................45
2.5.3 Elderly ...................................................................................................................................46
2.5.4 The orthopaedic footwear sector in Uk..................................................................................46
4A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
5.3.2 Research priorities.................................................................................................................82
5.4 Up-skill providers.........................................................................................................................86
5.4.1 Challenges .............................................................................................................................86
5.4.2 Research priorities.................................................................................................................89
5.5 End-user driven...........................................................................................................................94
5.5.1 Challenges .............................................................................................................................94
5.5.2 Research priorities.................................................................................................................96
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
5A A Strategic Research Agenda for the Footcare sector (2015-2020)
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”
6A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
7A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
8A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
9A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
10A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
11A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
12A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
13A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
14A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
15A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
16A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
17A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
18A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
19A A Strategic Research Agenda for the Footcare sector (2015-2020)
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”
20A A Strategic Research Agenda for the Footcare sector (2015-2020)
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%”
21A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
22A A Strategic Research Agenda for the Footcare sector (2015-2020)
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%)”
23A A Strategic Research Agenda for the Footcare sector (2015-2020)
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:
24A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
25A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
26A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
27A A Strategic Research Agenda for the Footcare sector (2015-2020)
 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
28A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
29A A Strategic Research Agenda for the Footcare sector (2015-2020)
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
responding to the challenges of diabetes with some strength in policies on plans, health systems and
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.
2.2.2 Overweight and obese
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
responding to the challenges of diabetes with some strength in policies on plans, health systems and
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”
30A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
31A A Strategic Research Agenda for the Footcare sector (2015-2020)
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/
32A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
33A A Strategic Research Agenda for the Footcare sector (2015-2020)
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”
34A A Strategic Research Agenda for the Footcare sector (2015-2020)
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”
35A A Strategic Research Agenda for the Footcare sector (2015-2020)
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”
36A A Strategic Research Agenda for the Footcare sector (2015-2020)
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).
Source: INE, Spanish National Statistics Institute.
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).
Source: INE, Spanish National Statistics Institute.
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
37A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
38A A Strategic Research Agenda for the Footcare sector (2015-2020)
References
 International Diabetes Federation. IDF Diabetes atlas. Sixth edition. 2014.
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
 International Diabetes Federation. IDF Diabetes atlas. Sixth edition. 2013.
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.
39A A Strategic Research Agenda for the Footcare sector (2015-2020)
 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.
40A A Strategic Research Agenda for the Footcare sector (2015-2020)
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"
2.4.2 Overweight and obese
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”
41A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
42A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
43A A Strategic Research Agenda for the Footcare sector (2015-2020)
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.
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sohealthy Project

  • 1.
  • 2. 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
  • 3. 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
  • 4. 3A A Strategic Research Agenda for the Footcare sector (2015-2020) 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 2.2.2 Overweight and obese ...........................................................................................................29 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 2.4.2 Overweight and obese ...........................................................................................................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 2.5.2 Overweight and obese ...........................................................................................................45 2.5.3 Elderly ...................................................................................................................................46 2.5.4 The orthopaedic footwear sector in Uk..................................................................................46
  • 5. 4A A Strategic Research Agenda for the Footcare sector (2015-2020) 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 5.3.2 Research priorities.................................................................................................................82 5.4 Up-skill providers.........................................................................................................................86 5.4.1 Challenges .............................................................................................................................86 5.4.2 Research priorities.................................................................................................................89 5.5 End-user driven...........................................................................................................................94 5.5.1 Challenges .............................................................................................................................94 5.5.2 Research priorities.................................................................................................................96 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
  • 6. 5A A Strategic Research Agenda for the Footcare sector (2015-2020) 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”
  • 7. 6A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 8. 7A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 9. 8A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 10. 9A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 11. 10A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 12. 11A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 13. 12A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 14. 13A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 15. 14A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 16. 15A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 17. 16A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 18. 17A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 19. 18A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 20. 19A A Strategic Research Agenda for the Footcare sector (2015-2020) 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”
  • 21. 20A A Strategic Research Agenda for the Footcare sector (2015-2020) 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%”
  • 22. 21A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 23. 22A A Strategic Research Agenda for the Footcare sector (2015-2020) 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%)”
  • 24. 23A A Strategic Research Agenda for the Footcare sector (2015-2020) 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:
  • 25. 24A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 26. 25A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 27. 26A A Strategic Research Agenda for the Footcare sector (2015-2020) 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
  • 28. 27A A Strategic Research Agenda for the Footcare sector (2015-2020)  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
  • 29. 28A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 30. 29A A Strategic Research Agenda for the Footcare sector (2015-2020) 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 responding to the challenges of diabetes with some strength in policies on plans, health systems and 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. 2.2.2 Overweight and obese 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 responding to the challenges of diabetes with some strength in policies on plans, health systems and 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”
  • 31. 30A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 32. 31A A Strategic Research Agenda for the Footcare sector (2015-2020) 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/
  • 33. 32A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 34. 33A A Strategic Research Agenda for the Footcare sector (2015-2020) 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”
  • 35. 34A A Strategic Research Agenda for the Footcare sector (2015-2020) 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”
  • 36. 35A A Strategic Research Agenda for the Footcare sector (2015-2020) 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”
  • 37. 36A A Strategic Research Agenda for the Footcare sector (2015-2020) 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). Source: INE, Spanish National Statistics Institute. 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). Source: INE, Spanish National Statistics Institute. 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
  • 38. 37A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 39. 38A A Strategic Research Agenda for the Footcare sector (2015-2020) References  International Diabetes Federation. IDF Diabetes atlas. Sixth edition. 2014. 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  International Diabetes Federation. IDF Diabetes atlas. Sixth edition. 2013. 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.
  • 40. 39A A Strategic Research Agenda for the Footcare sector (2015-2020)  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.
  • 41. 40A A Strategic Research Agenda for the Footcare sector (2015-2020) 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" 2.4.2 Overweight and obese 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”
  • 42. 41A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 43. 42A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.
  • 44. 43A A Strategic Research Agenda for the Footcare sector (2015-2020) 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.