DISSERTATION Critical Review Assignment 1

Honours Project MHB913252 S1218907
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School of Health and Social Care
Session 2015-2016
Diabetic hot spots: can they be predicted
using temperature monitoring tools and
subsequently prevent foot ulceration?

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Contents
Abstract.......................................................................................................................................3
Introduction.................................................................................................................................5
Methodology................................................................................................................................ 7
Findings ..................................................................................................................................... 13
Discussion.................................................................................................................................. 27
Conclusion ................................................................................................................................. 31
Acknowledgements .................................................................................................................... 32
Reference List............................................................................................................................. 33
Appendices ................................................................................................................................ 42

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Abstract
Background
Diabetes affects 1 in 11 people and this figure is rising rapidly - the level of diabetic foot
ulceration may also increase placing huge burdens on healthcare and individuals. Great
emphasis is placed on self-prevention practices, with temperature monitoring the new
strategy arising. The theory is ulceration is preceded by inflammation which could be
monitored using infrared thermometers to establish areas of impending breakdown, giving the
individual premonition like powers regarding their foot health status. However even though
temperature monitoring is utilised in other aspects of diabetes care, it is not the case with
diabetic foot ulceration currently, whereby no guidelines are available.
Aim
Therefore the aim of this literature review is to assess whether temperature monitoring is
fitting for foot practice by critically appraising current evidence regarding whether self-
temperature monitoring tools such as infrared thermometers are effective in predicting and
preventing areas of ulceration in diabetic individuals.
Methodology
This review was undertaken between September 2015 and February 2016, during which a
research question was established and a literature search of academic databases was
undertaken until the final four studies were reached. SIGN critical appraisal tools were used
to assess the studies methodological quality and eventual level of evidence.
Findings and Discussion
The articles included were reviewed and analysed thematically. An association between
temperature monitoring and reduced ulcer incidence was established, and it was noted in two
studies that ulceration sites experienced higher temperatures prior to the breakdown.
However results were not consistent among all studies, direct comparison was limited and the
methodological rigour was equivocal at times thus impacting internal validity and making it
difficult to draw solid conclusions.

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Conclusion
Overall this critical review highlighted that temperature monitoring is a promising advancing
technology in healthcare and has had mainly positive results regarding the prevention of
diabetic foot ulceration – an area of increasing focus. However further robust studies need to
take the next step to support these current findings before such tools are implemented in
practice.

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Introduction
Diabetes, according to Gale and Anderson (2012) is a common metabolic condition
characterised by chronic hyperglycaemia either from a complete lack of insulin known as
type 1 or relative lack of insulin and increasing insulin resistance – type 2. It is a growing
global issue: worldwide affecting a staggering 415 million adults (International Diabetes
Federation, 2015). However, this is predicted to rise to 642 million by 2040. Within Great
Britain, Diabetes UK (2015) reported 3.9 million people live with diabetes which is predicted
to rise to 5 million within the decade. Furthermore in Scotland there are 276,430 people with
diabetes -5.2% of the population; and 61,869 reside in Glasgow (McKnight et al, 2014).
A diabetic foot ulcer (DFU) is a wound distal to the ankle in diabetic patients which
penetrates the dermis, with possible involvement of deeper structures (Schaper, 2004). The
underlying disease process involves a physiological reaction resulting from repetitive minor
injury which induces an inflammatory process characterised by increased temperature at the
site; enzymatic autolysis of the tissue occurs leading to an ulcer (Sibbald, Mufti and
Armstrong, 2015). By being able to continuously monitor skin temperature using infrared
thermometry, subtle inflammation (>2ºC) be predicted earlier before for potential breakdown
before visible signs and measures installed to prevent these limb and subsequently life
threatening complications (Foto, Brasseaux & Birke, 2007).
DFUs are an important indicator of declining systemic disease and control. They are complex
and debilitating in nature whilst being multi-factorial in origin. A significant study by Reiber
et al (1999) identified numerous causal pathways that directly influence the pathophysiology
of foot ulceration. However the study found peripheral neuropathy, foot deformity and
trauma – known as the critical triad - the most common causal pathway. The study also
highlighted peripheral arterial disease (PAD) as a main player, with hyperkeratosis and
oedema to be among the foot ulceration team. Secondary factors that increase a person’s risk
include: ill-fitting footwear, long duration of DM, poor glycaemic control, smoking,
increased BMI, and ultimately previous ulceration or amputation (Fard, Esmaelzadeh &
Larijani, 2007).Throughout a diabetic person’s lifetime, risk of developing DFU is 12-25%,
with prevalence ranging from 4-10%, and recurrence rates greater than 50% after three years
(Ghosh & Collier, 2014; Singh, Armstrong & Lipsky, 2005; Boulton et al, 2005). In

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Scotland, 13,476 of the diabetic population have reported having a foot ulcer – figures from
Glasgow represent roughly a quarter of this total at 3,065 (McKnight et al, 2014).
DFUs are often instigators of terrible limb-threatening cascades of events: they can become
non-healing and chronic (Fonder et al, 2008); increasing the risk of diabetic foot infection
(Edmonds and Foster, 2014), thus becoming more susceptible to necrosis and amputation. As
a result diabetes is the biggest culprit of non-traumatic lower extremity amputations - DFUs
precede lower limb amputation in a staggering 80% of cases according to NICE (2015).
Unfortunately as a result, following amputation mortality rates are high; within 1 year 13% to
40%, 35% to 65% at 3 years, and by 5 years 39% to 80% (Singh, Armstrong & Lipsky,
2005).
DFUs are often avoidable; healthcare has shifted to ‘prevention is the best cure’ as part of
health promotion plans. The main current preventative strategies installed include: patient
education, self-inspection, regular foot screenings and risk stratification, podiatry and MDT
intervention, quality appropriate footwear and orthoses (Ghosh and Collier, 2012).
A study by Armstrong and Lavery (1997) investigated the effectiveness of temperature tools
in monitoring progression and healing of other diabetic foot complications such as Charcot
neuroarthropathy with positive results. According to SIGN (2013), Charcot diagnosis is based
on clinical examination (inflammation) accompanied by a temperature increase between 2 to
8 ˚C compared to the contralateral foot. Current practice in the UK: temperature monitoring
tools are primarily used successfully and regularly to identify the presence of Charcot
arthropathy, and subsequently monitor its disease activity progression and evaluate treatment
effectiveness. However could this be successfully transferred to identification of DFU?
Therefore, the aim of this review is to investigate whether self-temperature monitoring tools,
specifically infrared thermometers are effective devices in predicting and subsequently
preventing ulceration in diabetic individuals.

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Methodology
October 2015: brainstorming surrounding DFU emphasised the impact on individuals,
podiatrists, the health service and potential service improvements regarding indicative
preventative measures (figure 1). This facilitated conceptualisation of the research topic.
Initial browsing ensued to examine preliminary literature (table 1). A research question was
then established – Aveyard (2010) states research questions focus an initial hypothesis, which
once answered should improve patient care through informed recommendations and superior
understanding of the subject area owing to evidence based practice (EBP). The PICO tool
developed the research question: does the use of self-temperature monitoring tools such as
infrared thermometers (intervention), effectively predict and subsequently prevent the
development of foot ulcers (outcome) in diabetic patients (population) compared to existing
standard preventative measures (comparison)? The PICO design improves detection of high
quality evidence, facilitates structured research and breakdown of the question into four
easily identifiable aspects for efficient precise searching (Aslam & Emmanuel, 2010).

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Figure 1: Initial Brainstorm Mindmap (References can be found in Appendix 1)

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Table 1: Initial Browse
ResearchTopic Initial
Terms
Site Papers Returned
Utilising
temperature
monitoring as a
diagnostic
preventative tool
for diabetic foot
ulceration.
“temperature
monitoring”
AND
“diabetic foot
ulceration”
a.GCU Discover a. 4,082
b.248,000 Yielded too many non-academic
and irrelevant results
c.19,400
b.Google
c.Google
Scholar
SIGN Guidelines
(2013)
Guideline 116: Management of Diabetes
 Minimal guidance on preventative measures for ulceration,
only footwear and orthoses mentioned.
 Patient education is recommended.
 Thermometry can be used to identify Charcot, and then can be
used to monitor post diagnosis Charcot disease activity
treatment: as total contact casting of affected limb should
coincide with temperature reduction.
-lacking guidance in preventing and diagnosing areas of foot
ulceration.
NICE Guidelines
(2015)
NG 19: Diabetic Foot Problems: prevention and management
 Guidance surrounding preventing diabetic foot problems by
assessing the feet regularly for neuropathy (using tools e.g.
monofilament), PAD,look for areas of potential or actual
ulceration – could this be improved?
 Temperature monitoring used in evaluating treatment of
Charcot. Charcot is likely to be resolved when temperature
differences between both feet are <2 ˚C.
-Further Research Recommendations: intensive monitoring for
people at risk of diabetic foot complications.
Cochrane Review
 Hoogeveen,
Dorresteijn,
Kriegsman &
Valk (2015)
Complex interventions for preventing diabetic foot ulceration
 Evaluating complex preventative interventions e.g.
combination of patient self-care,healthcare providers
(podiatrists) and structured health care (MDT approach)
compared to single or other complex interventions.
- No mention of temperature monitoring as a tool to prevent
DFUs.
It is clear from initially browsing the available literature, that temperature monitoring appears to be recommended as a means
of aiding diagnosis and monitoring post diagnosis treatment outcomes in charcot arthropathy. It does not appear to be used in
any other aspect of diabetes care currently in the UK (predicting/preventing areas of ulceration) by practitioners e.g. as part of
professional assessments or even advised for patients e.g. for self-help/ educational purposes.
This therefore indicates a need for this review to be conducted.

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A literature search (table 2) was undertaken early November 2015 inspecting fundamental
academic databases; AMED, CINAHL, MEDLINE and Health Source were all searched
simultaneously via EBSCO Host with duplicates removed. Cochrane Library, ProQuest and
Web of Science were searched separately (Appendix 2). Main search terms included
“temperature monitoring”, “handheld”, “predicting”, “preventing”, “diabetic foot ulceration”
and suitable synonyms. Boolean operators and truncation yielded focused productive results.
Refinement included limiting publication dates to within 2004-2015 - it was noted during
initial research multiple studies were conducted broadly on this subject field over 1980s-
1990s, succeeded by a literature gap until mid-2000s when interest sparked again. Therefore
the decision was made to generate the most recent, updated literature for appraisal; hopefully
attaining more relevant conclusions.
Search results were evaluated and studies included if they met predefined eligibility criteria
(table 3). Thereafter four studies resided, manual searching of references was undertaken
ensuring potential relevant articles were not overlooked. This revealed supplementary
studies; however these were then discarded after applying such criteria.
Literature appraisal: the SIGN (2015a) algorithm for classifying study design for questions of
effectiveness indicated using the RCT Methodology Checklist (SIGN, 2015b). This enables
consistent inspection of study validity and comparability through reducing appraiser bias.
According to Baker et al (2010) the checklist is structured and simple, promoting ease of use.
Appraisal allows researchers to determine authenticity allowing graded recommendations to
be made about the level of research evidence (Rychetnik et al, 2002). Appraisal process can
be sought in appendix 3.

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Table 2: Literature Search Strategy
Search
terms
“temperature monitoring” OR “thermometry” OR “skin temperature” OR “temperature tool” OR
“temperature regulation” OR “infrared thermometry”
AND
“self-monitoring” OR “self-assessment” OR “home monitoring” OR “handheld”
AND
“diabetic foot ulceration” OR “DFU” OR “foot ulcer” OR “foot complication” OR “diabetic ulcers”
OR “diabetic wound” AND “prevention” OR “prediction”
Databases
searched
AMED, CINAHL, Cochrane Library, MEDLINE, Health Source: Nursing/Academic Edition, ProQuest
Health and Medical Complete, ProQuest Nursing and Allied Health Source, Web of Science
Part of
journals
searched
 Keywords in Title
 Keywords in Abstract and Summary
 fewer number of articles yielded but also reduced volume of articles that are not relevant
Years of
search
 2004-2015
 only interested in analysing most recent literature
Language  English
 to facilitate reviewer interpretation although trials could be conducted internationally
Types of
studies to
be
included
 Randomised Controlled Trials (RCTs)
 highest level of trial evidence
 published papers only in peer reviewed journals to ensure credibility
 Quantitative Research
Inclusion
criteria
 Patients diagnosed with Diabetes (type 1 or type 2)
 Males and Females
 All ethnic origins and equalities
 Adults >18 years old
 High Risk Status
 Use of self-assessment temperature monitoring tools specifically infrared thermometers
 Main outcome looking at incidence of foot ulceration
Exclusion
criteria
 Other systemic diseases
 Active ulceration
 Active infection and charcot arthropathy
 Alcohol abuse
 Animal studies
 Studies using thermal imaging techniques or non-handheld temperature devices
 Primary outcome looking at post diagnosis disease monitoring of charcot neuroarthropathy

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Table 3: Review Eligibility Criteria

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Findings
Literature Gathering Results
Succeeding the literature search, over four hundred articles were gathered for screening and
papers diminished until the final four articles remained as in figure 2. Thorough literature
review tables can be found in Appendix 4. All four studies (Lavery et al, 2004; Lavery et al,
2007; Armstrong et al, 2007; Skafjeld et al, 2015) were randomised controlled trials (RCTs).
According to Stolberg, Norman and Trop (2004), RCTs are regarded as the strongest type of
evidence; they are designed to have a low probability of bias and less methodological errors
(Burns, Rohrich and Chung, 2011).
Study Results
Table 3 displays specific study results. Three studies (Lavery et al 2004; Lavery et al 2007;
Armstrong et al 2007) found statistically significant reduced ulcer incidence rates in the
intervention compared to controls: indicating self–assessment infrared thermometers –
specifically TempTouch (figure 3) appears to be an effective complementary tool to standard
measures to prevent DFU. However, the final and most recent study findings (Skafjeld et al,
2015) were not in agreement whereby ulcer incidence was non-significant between groups.

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Figure 2: PRISMA Flow Diagram
Records identified through
database searching:
AMED, CINAHL,Health Source,
MEDLINE (n =78)
Cochrane Library (n = 4)
ProQuest Health - Nursing and
Allied Health (n= 284)
Web of Science (n= 63)
Total = 1,579
ScreeningIncludedEligibilityIdentification
Additional records identified
through other sources
(n=10)
-Reference Lists
Records after duplicates removed
(n = 393)
Records screened
(n = 393)
Records excluded after screening
title and/or abstract
(n=205)
 Non RCTs (98)
 Letters to the author or expert
commentaries (16)
 Newspaper/Magazine articles
(12)
 Not in English – e.g. title in
English but abstract in foreign
language (5)
 Full text not available (42)
 Studies on animals (3)
 Miscellaneous (29)
Full-text articles
assessed for eligibility
(n =188)
Full-text articles excluded, with
reasons
(n = 184)
 Papers not relevant to research
question - off topic or does not
answer question (102)
 Not evaluating temperature
monitoring of feet (8)
 Not self-assessment tools – e.g.
thermal imaging (31)
 Studies involving venous leg
ulcers or active DFUs (36)
 Miscellaneous (7)
Studies included in
review
(n = 4)
Overall Total
= 439

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Table 4: Studies Results

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Figure 3: TempTouch Device
Lavery (2007)
Rogers and Frykberg (2008)
*Note: TempTouch is characterised as an infrared contact dermal thermometer. It has a touch
sensor tip to detect skin contact. Temperature results are displayed on LCT screen. The large
curved design or ‘gooseneck’ facilitates the person to access most areas of the foot for
measurement, although this may still be difficult for the elderly, those who are obese (obesity
significantly associated with type 2 diabetes) and those with structural deformity.
Lavery et al (2007) and Armstrong et al (2007) were the only studies to provide a description of
the device.

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Articles will be thematically discussed to provide a concise, synthesised review of study
features. Themes were identified as areas of notable discussion by the reviewer; however this
is by no means absolute.
Primary Outcome Measure
Positively, all four studies measured the same primary clinical outcome: foot ulcer incidence
- participants either did or did not develop a DFU (dichotomous outcome) throughout the
study course. However, variation occurred regarding methods of measuring ulceration, which
limits direct comparison between the studies (Liberati et al, 2009). Whilst, NICE (2015)
emphasise practitioners should use a standardised diagnostic system to ensure neutrality; two
studies (Lavery et al, 2004; Armstrong et al, 2007) used no or unspecific criteria for ulcer
classification – poor objectivity. Encouragingly the remaining two studies (Lavery et al,
2007; Skafjeld et al, 2015) utilised universally established wound grading systems: The
University of Texas Wound Classification (UTC) and Wagner Ulcer Classification (WC)
respectively. Multiple studies (Oyibo et al, 2001; Gul et al, 2006) comparing the two systems
found UTC to be the optimal tool – as it provides further in-depth information; taking into
account the presence of infection and ischaemia. Nevertheless, Armstrong, Lavery and
Harkless (1998) emphasised that only by using a justified, evidence based system can ulcers
be appropriately, objectively measured. This suggests that even though UTC appears to be
the preferred method; using some form of classification system is superior to none and
eliminates practitioner subjectivity.
Inclusion and Exclusion Criteria
The purpose of establishing eligibility criteria is to minimize harm and ensure the subjects
investigated represent the target population as accurately as possible (Coggon, Rose &
Barker, 2003). All papers stated participants must have a diagnosis of diabetes; however
differences occurred regarding sub groups. Only two papers (Lavery et al, 2007 and Skafjeld
et al, 2015) included both type 1 and type 2, with the other two studies (Lavery et al, 2004;
Armstrong et al, 2007) either not specifying or only including type 2 respectively. This may
reduce the comparability between all studies and limit generalisability of the latter two
studies as although type 2 is more common, ulceration does not distinguish between
subgroups, presenting in both cases, but instead is dependent on risk status, control and
disease duration. Moreover, Armstrong et al (2007) only recruited US Veterans and may
reduce generalisability of the findings. In three papers (Lavery et al, 2004; Armstrong et al,

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2007; Skafjeld et al, 2015), participants had to be either risk group 2* or 3 according to the
International Working Group on the Diabetic Foot classification tool (table 5). It is important
to note than in one study (Skafjeld et al, 2015); participants had to be eager to monitor foot
skin temperature, therefore introducing a sample selection bias and reducing the external
validity of this trial (Polgar & Thomas, 2013).
Table 5: International Working Group on Diabetic Foot Risk Classification System (Bus et al
(2015)
All studies excluded active ulceration, infection and Charcot arthropathy as well as open
amputation sites which would increase skin temperatures. Furthermore, participants were
excluded in all studies if they were deemed to have peripheral vascular disease – which
seems to be contradictory to the inclusion criteria* - with three studies (Lavery et al, 2007;
Armstrong et al, 2007; Skafjeld et al, 2015) highlighting this had to be severe or ischaemic,
as this can cause excessively cool tissues and may mask hot spots impacting results.
Armstrong et al (2007) specifically stated that patients were to be excluded if they had
impaired vision. However, this is understandable and improves robustness due to the self-
assessment trial nature; performing foot inspections or utilising infrared thermometers
(required to read and record temperature values on the screen) requires satisfactory sight
according to Hughes (2007). Future vision: devices could be developed with sound to
incorporate those with optical impairment. Lastly, dementia or impaired cognition was a
criterion (Lavery et al, 2004; Lavery et al, 2007; Armstrong et al, 2007); justifiably as this
can impact ability to self-care but also affects mental capacity regarding informed consent
(National Institutes of Health, 1999; Higgins, 2013) and thus demonstrates ethical
mindfulness.
Risk Group Classification Risk Factors Present
0 No peripheral neuropathy
1 Peripheral neuropathy
2 Peripheral neuropathy with peripheral arterial disease (PAD)* and/or a foot
deformity
3 Peripheral neuropathy and a history of foot ulceration or lower extremity
amputation

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Study Methods
Sample Size, Justification, and Drop-out:
It is impractical and costly to study entire target populations - researchers investigate
representative samples and attempt to generalise the findings. Therefore selecting an
appropriate sample size is important; in health research it is implied there is no optimal
number (Polgar & Thomas, 2013). Although generally, larger sample sizes produce more
accurate results and achieves higher power. Sample sizes were diverse; two studies (Skafjeld
et al, 2015 and Lavery et al, 2004) had notably fewer participants of 41 and 85, whilst the
remaining studies (Lavery et al, 2007 and Armstrong et al, 2007) had 173 and 225
respectively – cumulating to 524. Only the two larger studies provided justification of
determined sample size and increases robustness of these trials (Lavery et al & Armstrong et
al 2007). The former chose a power of 80% to yield 60 subjects per group with the aim that
55 would complete the study after accounting for an expected 10% drop out rate. However
this target was not met: each treatment arm allocated fewer than 60 participants and overall
the study dropout rate was 12.71%, with individual group dropout rates calculated higher
than anticipated suggesting the study may be slightly underpowered to detect a significant
effect. For details regarding drop out figures of the three studies that provided this (Lavery et
al, 2004; Lavery et al 2007; Skafjeld et al 2015), manually composed graphs depicting these
can be found in figure 4. Armstrong et al (2007) identified that an estimated sample size of 70
per group: as no information was revealed regarding group sample sizes or dropout, it is
unclear if this was achieved.

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0
2
4
6
8
10
Enhanced Therapy Standard Therapy Study: Total
DropOutPercentage(%)
Lavery et al (2004)
Figure 4: Dropout Statistics and Justifications
Justifications and Figures Group Total
Involuntary Withdrawal Voluntary Withdrawal
No specified reasons
Enhanced Therapy
(n=41)
0 3 3
Standard Therapy
(n=44)
0 4 4
Study: Total (n=85) 7

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0
5
10
15
20
Enhanced TherapyStructured TherapyStandard Therapy Study: Total
Lavery et al (2007)
Justifications and Figures Group
Total
Foot
Trauma
Fracture Osteomyelitis
(no ulcer)
Death Motor Car
Accident
Myocardial
Infarction
Too much to
do
Moved out
of town
Enhanced
Therapy
(n=58)
1 1 0 1 0 1 6 0 10
Structured
Therapy
(n=56)
0 2 1 0 1 0 2 0 6
Standard
Therapy
(n=59)
1 0 0 2 0 0 2 1 6

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0
2
4
6
8
10
12
14
16
Enhanced Therapy Standard Therapy Study: Total
Skafjeld et al (2015)
Justifications and Figures Group
Total
No specified reasons
Dropout Illness
Enhanced
Therapy (n=21)
0 1 2 3
Standard
Therapy (n=20)
0 0 0 0

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Randomisation, Group Allocation, Concealment and Blinding:
All studies stated randomisation was performed; however Lavery et al (2004) provided no
further information, thus the reader cannot be certain this was truly undertaken. One study
Skafjeld et al (2015) performed block randomisation and in addition, patients with previous
Charcot arthropathy were stratified. The remaining studies performed simple randomisation
(Armstrong et al, 2007 & Lavery et al, 2007) by generated randomised lists; specifically via
the study biostatistician who sequentially assigned patients and computer generated
respectively– the latter therefore reduces the risk of human error and bias. Additionally this
was the only study to address randomisation concealment whereby allocation was sealed in
opaque envelopes, this is a positive aspect as allocation concealment is critical and influences
success of randomisation (Viera and Bangdiwala, 2007), as its absence can lead to selection
bias. As Doig and Simpson (2005) highlighted, vague or unsatisfactory concealment methods
can produce 40% greater biased estimates of treatment effect. Regarding group allocation,
participants were randomised equally. However, Armstrong et al (2007) did not disclose
group sample figures, therefore it is unknown how many subjects were in each group or if
there was a possible allocation bias (as this was the study randomised via the study
statistician), therefore leaving the reader sceptical. Finally, all four studies stated single
blinding was initiated. The manner of these trials does not enable double blinding which is
often regarded as achieving a higher standard of scientific rigour. However according to
Coggan, Rose and Barker (2003), when the study endpoint is a subjective physical sign (e.g.
an ulcer); it is more beneficial for the investigating physician to be masked about which
patients received the enhanced intervention. Positively, three studies (Lavery et al, 2004;
Lavery et al, 2007; Armstrong et al, 2007) specifically stated the treating physician was
blinded to group allocation (it appears study nurses and possibly podiatrists were not blinded
however this is unclear). Furthermore, the latter two studies mentioned minimally that
blinding was maintained but did not report on whether this was successful via participants
being asked not to discuss treatment group assignment; however this is not a diligent method
and cannot be completely controlled.
Follow-Up Duration
Study duration was wide ranging from the shortest 6 months (Lavery et al, 2004) to 18
months (Armstrong et al, 2007). According to Melton (2010), optimum follow up duration is
governed by the type of outcome being measured. As the outcome being measured in the

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studies is foot ulcer incidence which is infrequent and transient, longer follow up periods (> 1
year) would be preferred and is achieved by three studies.
Study Design
Baseline Characteristics
Positively all four studies presented tables according to the methodological guidelines
CONSORT 2010 Statement , which highlighted study treatment groups were comparable in
baseline characteristics, with Lavery et al (2007) and Skafjeld et a (2015) providing more
extensive information. Three studies (Lavery et al, 2004; Armstrong et al, 2007; Skafjeld et al
2015) carried out significance testing of baseline demographics despite this being advised
against by the CONSORT group as being inessential and deceiving – dissimilarity regarding
baseline characteristics are a consequence of chance rather than bias (Moher et al, 2010).
Control Classification
Each study can be classified as active (positive) controlled trials consisting of existing
standard preventative therapy. According to Miller and Brody (2002) and SIGN (2014) this is
favourable and ensures studies are morally sound; if proven effective standard therapy exists
then it is deemed unethical to compare enhanced therapy to placebo/no treatment (negative
controls).
Intervention Protocol
All papers evaluated the effectiveness of the same infrared thermometer – TempTouch, ergo
incrementing homogeneity. Every study compared at minimum two groups: intervention
(infrared thermometry plus standard therapy) compared to a control (standard therapy alone).
Additionally, Lavery et al (2007) included a third treatment arm (structured foot inspections
plus standard therapy); this proved to be no more effective than standard therapy alone and
did not significantly impact results instead highlighting the observed effect is independent of
increased visual foot examination. Conversely, Skafjeld et al (2015) implemented a further
independent variable in the intervention - theory based counselling, thus makes it difficult to
separate observed effects and limits direct comparison among studies.
As each treatment arm contained standard therapy, with the only difference being the addition
of the independent variable infrared thermometry, thus assuming differences regarding
outcomes can be attributed to the temperature monitoring.

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Outcome Statistics and Analysis
For analyses, all studies used significance levels equal to 0.05 or less and prominently
reported p-values in their results. Whilst P values express whether an effect exists; it does not
identify the magnitude of such effect. Therefore in quantitative studies, whilst p values
(statistical significance) remain essential, the effect size (substantive significance) should be
the fundamental finding (Sullivan & Feinn, 2012). Three studies (Lavery et al 2004; Lavery
et al 2007; Armstrong et al 2007) used an indirect measure of effect size known as odds ratios
(OR) regarding ulcer incidence; although this was not explicitly stated (table 6). ORs are
effective when outcomes are dichotomous as in this case, but generally are utilised in case
control studies. Nevertheless literature (Knol et al, 2011 & Osborne, 2006) have shown ORs
are still popular in RCTs - 1 in 8 with dichotomous outcomes used OR for primary outcomes;
however ORs can inflate effect sizes and are difficult to interpret by the public, practitioners
and even researchers, therefore should only be reported if accompanied by accurate
clarification of implication which was not the case here thus should be interpreted with
caution.
Three studies (Lavery et al, 2004; Lavery et al, 2007; Skafjeld et al, 2015) performed
intention to treat analysis (ITT) - regarded as the gold standard of statistical reporting in
RCTs as it maintains treatment comparability (Armijo-Olivo, Warren and Magee, 2009). ITT
analyses participants in the groups to which they were randomised therefore preserving the
benefits of this bias reducing process. Ideally ITT requires a complete set of data; however
RCTs commonly suffer from dropouts and missing outcome data, as was the case in these
studies. In this scenario data is either excluded altogether which may result in underpowered
biased results, or ITT can be upheld via imputation such as last observed value carried
forward (LOCF) which was undertaken in only one of the trials that performed ITT analysis
(Lavery et al, 2007), however this method is subject to controversy as it relies on assumptions
(Altman, 2009). In Lavery et al 2007, there was increased dropouts in the intervention
compared to the control - according to Molnar, Hutton and Fergusson (2008) using LOCF in
such cases may bias results in favour of the intervention and reduce the results validity.

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Table 6: Effect Sizes
Study Statistical Analysis Interpretation
Lavery et al
(2004)
Enhanced therapy versus standard therapy odds of
developing foot complication
 OR 10.3 – large effect size
 Confidence interval (1.2-85.3) – Width= 84.1
Enhanced therapy ten times less likely to ulcerate compared to
standard therapy.
As the confidence interval does not contain the value of no
effect (OR 1), then it can be concluded there is a statistically
significant correlation.
Smaller studies usually have wider confidence intervals and this
is the smallest of the three studies.
However, wide confidence interval indicates the precision of
effect is actually unknown and more information is required
even though the odds ratio suggests it’s a large effect.
Lavery et al
(2007)
developing foot ulceration
 OR 4.48 – medium effect size
 Confidence interval (1.53-13.14)
Width = 11.61
Enhanced therapy versus structured therapy odds of
 OR 4.71 – medium effect size
Width = 12.25
4 times less likely of ulcerating in the enhanced therapy than
both standard therapy and structured therapy.
As the confidence interval does not contain the value of no
effect (OR 1), then it can be concluded there is a statistically
significant correlation.
Armstrong
et al (2007)
 OR 3.0 –small effect size
Width = 7.5
Enhanced therapy group are three times less likely to ulcerate
than the standard therapy.
Narrow confidence interval suggests more accurate effect.
However, as confidence interval includes the value of no effect
(OR 1), then it actually suggests that results are not clinically
significant.
Strengths and Limitations of Studies
Two authors (Lavery & Armstrong) were involved in three of the studies; both of whom are
experts with a wealth of publications in this field. However, two of these studies (Lavery et al
2004 & Lavery et al 2007) were published by the exact same research group, with multiple
authors being: paid consultants, on advisory or members board, on the board of directors and
hold stock in Xilas Medical - manufacturer of TempTouch, which may indicate possible bias
and could be a subsequent limitation. This must be taken into consideration when analysing
the results; as all three common authorship studies found favourable statistically significant
results indicating temperature monitoring to be more effective compared to standard therapy.
Whereas the final fourth study conducted by alternate authors did not identify any statistical
significance in foot ulcer occurrence between groups.
Note: Odds Ratio Effect Sizes (Olivier and Ball, 2013)
Small: 1.5 Medium: 3.5 Large: 9

Page | 27
Discussion
These results have extended evidence, acknowledging an interesting link regarding raised
temperatures being indicative of impending ulceration and that statistically confident
correlations may exist between utilising infrared thermometers and reduced ulcer incidence,
supporting its use as an advantageous adjunctive therapy to existing therapies. Nevertheless,
suboptimal reporting of vital information or methodological procedures among the studies
was a consistent issue. Understandably this rendered the reviewer uncertain of bias reducing
aspects which were deemed to have occurred poorly or not at all – implying reduced internal
validity. However, a study by Devereaux et al (2004) evaluated levels of non-reported
procedures to actual procedure occurrence levels in RCTs and concluded readers should not
make assumptions regarding non-reported content. This could be a limitation of the
researcher, showcasing haste and inexperience. Regardless clinicians rely on ably conducted
RCTs and their results as part of EBP to make informed clinical recommendations. Therefore
it plausible to advocate improved reporting by authors to: facilitate repeatability, ensure
accurate analysis and avoid ambiguity; as ultimately this could impact interpreter critique and
results.
Patient Impact
Prior to implementation, patients should receive appropriate evidence regarding the purpose
and results of infrared thermometers, therefore adhering to informed participative patient
centred care. Furthermore, users would need to be instructed on how to use the device
correctly to ascertain optimal benefits. Standardised procedures would be required: how
many measurements per day and when, whether feet temperatures need to acclimatise and
whether average measurements should be calculated - issues not highlighted by the studies
included in this review.
Compliance would be a focal issue as this is a patient self-therapy. However, Frykberg, Tallis
and Tierney (2009) conducted a clinical survey evaluating another self-assessment
temperature tool known as TempStat - subjects stated if they were given the device to use at
home; it would be beneficial and utilised daily. Although this cannot be directly transferable
to TempTouch, it represents initial inclination this is an area patients are eager to see
developed.

Page | 28
Gale and Anderson (2012) highlighted many psychosocial implications of DM; most people
undergo feelings of learned self-helplessness, powerlessness or condition consumption at
stages and may suffer from mental ill health - diabetes is linked to increased risk of
depression. This is often associated with poorer physical outcomes and may create resistance
to or impact a person’s ability to self-manage. ‘On the other foot’, this tool has an opportunity
if implemented with the right professional support to integrate mental and physical health by
promoting self-care and patient empowerment – as Diabetes Scotland (2015) noted, people
need to feel mentally empowered to govern their physical diabetes.
Clinical Implications:
Podiatry and Multi-Professional Context
Two included studies highlighted patients using TempTouch contacted study personnel more
frequently regarding increased temperatures, clinically this could transfer to increased
workload for podiatrists and foot protection teams, where patients could expect additional
treatment based on results. When increased temperatures were recorded, all of the studies
advised participants to reduce physical activity, although previous research by Armstrong et
al (2004) found high risk patients who ulcerated were actually on average less active which
seems contradictory. Alternatively, identifying ulceration hot spots, podiatry treatment could
be better tailored for more precise pressure distribution.
Ideally all health professionals’ part of the patient’s multi-disciplinary team would have a
role; particularly supporting and encouraging patients. This is especially true of diabetes
educators – who actively promote self-management. Freed (2008) highlighted infrared
thermometers are great tools not only for educating patients regarding the implications of
increased temperatures predicting and preventing DFU, but also motivating other aspects of
self-care and can aid patients to control their blood glucose more aggressively.
Although this review evaluates temperature monitoring as a self-prevention technique, it
could be targeted at podiatrists and other health professionals in clinical settings. Whereby,
during foot risk screenings, podiatrists could record foot temperature measurements onto the
online tool SCI-DC where patterns may be observed and tracked, in the same manner as
HbA1c scores. It may also be useful in inpatient settings where less than half of admissions
receive foot screening and 1.4% of diabetic inpatients develop new foot lesions (Health and
Social Care Information Centre, 2014). Nurses could monitor patient’s temperature for

Page | 29
Combined Cost: Foot Ulceration
and Amputation
(Diabetes Scotland, 2015)
Cost of Amputation
(Patonet al, 2011; Hogan, 2011; NHSLondon,
2012)
Cost to heal 1 ulcer
(Posnett & Franks, 2008)
• £64-66 million
• Direct = £8,459
- Foot: £8,200
- Leg: £11,600
• Indirect = up to £65k
• £5,200
impending ulceration – further improving foot checks as part of the national inpatient
initiative of the ‘CPR for Feet’ campaign by the Scottish Diabetes Foot Action Group (The
Scottish Government, 2014).
Cost Considerations
Regarding health economics, TempTouch roughly costs $150 or £103 according to McCurdy
(2008). It generally appears to be a low cost diagnostic preventative device that could be used
as an adjunct with standard preventative measures available at the NHS’s disposal, compared
to the expense of ulceration and amputation (Figure 4).
Figure 4: Average NHS Costs of Diabetic Foot Complications
Recommendations
Future Research
Further research should involve additional alternative research groups conducting studies to
discern if similar conclusions would be drawn and additionally evaluate other infrared
thermometers. Two trials have been identified currently underway: one evaluating the cost
effectiveness of temperature monitoring compared to standard therapy in reducing DFU and
the other is evaluating whether temperature monitoring incorporated with SMS and voice
messaging will reduce DFUs and improve compliance. Results of these trials are due to be
published in 2018 and 2017 respectively. It is evident this is an advancing research area with
opportunity for development and investment.

Page | 30
Future Innovations
The Scottish Government (2014) highlighted its priority to improve development of
innovative tools for diabetes care. One proposal could be for the concepts of two different
types of temperature monitoring to merge: devices encompassing LCT thermographs, where
patients stand on a thermal plates or sensors in shoes to generate full foot general visual
images, followed by more precise thermometry of hot spots where actual temperature figures
are measured to provide more comprehensive monitoring.
Current Review Limitations
Access to certain journals was restricted, therefore full scope of literature was unavailable;
cannot be sure all relevant evidence was included. Furthermore, literature was limited to
English language due to the unilingual interpreter. Reviewer inexperience in research and
critical analysis is a major drawback, as is pressure resulting from working towards a short
deadline and limited word availability; analysis may be restricted. Lastly, applying search
limiters excluded known relative notable studies (Stess et al, 1986; Benbow et al, 1994 and
Armstrong et al, 1997) which could have further impacted the results positively. These
studies highlighted temperature monitoring is a successful ulceration screening tool, and that
raised areas of foot temperature seem to be predictive of impending ulceration.

Page | 31
Conclusion
Currently there are no guidelines surrounding temperature monitoring for diabetic foot
ulceration therefore it is not used routinely by patients or the NHS; however this review
highlights the promising potential of infrared thermometry in predicting and preventing
ulceration. In addition to standard therapies, results predominantly established statistically
significant correlations regarding temperature monitoring to be effective in preventing
ulceration; although this was not consistent across all studies. Furthermore, poor
methodological rigour may reduce the credibility of the results. Therefore to substantiate
current evidence - more meticulous studies need to be undertaken before this device could be
implemented into UK practice. Ultimately, DFU is potentially limb and life threatening,
which is costly both to patient quality of life and the healthcare economy; hence innovations
in strategies to assist prediction and prevention could be valuable to all feet involved – with
temperature monitoring a compelling contender.

Page | 32
Acknowledgements
I would like to express my gratitude to my supervisor Professor Stuart Baird for his guidance,
advice, intellectual discussions, reassurance and patience regarding this project. I would also
like to thank my honours group consisting of colleagues and friends for suggestions and peer
support throughout. Finally I would like to recognise my close family and friends for
maintaining my motivation and providing emotional support.

Page | 33
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STESS, R.M. et al., 1986. Use of liquid crystal thermography in the evaluation of the diabetic
foot. Diabetes Care [online]. 9 (3), pp. 267-272. [viewed 12 January 2016]. Available from:
http://care.diabetesjournals.org/content/9/3/267.abstract
STOLBERG, H.O., NORMAN, G. & TROP, I. 2004. Randomized Controlled Trials. The
American Journal of Roentgenology [online]. 183 (6), pp. 1539-1544. [viewed 17 December
2015]. Available from: http://www.ajronline.org/doi/pdf/10.2214/ajr.183.6.01831539
SULLIVAN, G.M. & FEINN, R. 2012. Using Effect Size – or Why the P Value Is Not
Enough. Journal of Graduate Medical Education [online]. 4 (3), pp. 279-282. [viewed 1
February 2016]. Available from: doi: 10.4300/JGME-D-12-00156.1
THE SCOTTISH GOVERNMENT, 2014. Diabetes Improvement Plan [online]. The Scottish
Government. [viewed 5 February 2016]. Available from:
http://www.gov.scot/Publications/2014/11/6742/3
VIERA, A.J. & BANGDIWALA, S.I. 2007. Eliminating Bias in Randomized Controlled
Trials: Importance of Allocation Concealment and Masking. Family Medicine [online]. 39
(2), pp. 132-137. [viewed 30 January 2016]. Available from:
http://www.stfm.org/fmhub/fm2007/February/Anthony132.pdf

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Appendices
Appendix 1: Brainstorm Mindmap References
Appendix 2: Databases Searched
Appendix 3: Evidence of Critical Appraisal Methods Process
a - SIGN Classifying Study Design for Methodological Appraisal
b - SIGN Methodological Appraisal Checklist for RCTs
c - SIGN Guidance Notes for Methodological Appraisal Checklist for RCTs
d- SIGN Level of Evidence and Grading Recommendations
e - SIGN Methodological Appraisal of All Studies Checklist and Evidence Grading
Appendix 4: Literature Review Tables
Appendix 5: CONSORT 2010 Checklist

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Appendix 1: Additional References - Brainstorm Mindmap
(1). MCINNES, A.D. 2012. Diabetic foot disease in the United Kingdom: about time to put
feet first. Journal of Foot and Ankle Research [online]. 5 (26). [viewed 22 October 2015].
Available from: http://jfootankleres.biomedcentral.com/articles/10.1186/1757-1146-5-26
(2). UBEL, P.A. et al., 1988. Public preferences for prevention versus cure: what if an ounce
of prevention is only worth an ounce of cure? Medical Decision Making [online]. 18 (2), pp.
141-148. [viewed 22 October 2015]. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/9566447
(3). WOUNDS INTERNATIONAL, 2013. International Best Practice Guidelines: Wound
Management in Diabetic Foot Ulcers [online]. Wounds International. [viewed 22 October
2015]. Available from:
http://www.woundsinternational.com/media/issues/673/files/content_10803.pdf
(4). GILPIN, H. & LAGAN, K. 2008. Quality of life aspects associated with diabetic foot
ulcers: a review. The Diabetic Foot Journal [online]. 11 (2), pp. 56-62. [viewed 22 October
2015]. Available from: http://uir.ulster.ac.uk/26368/1/GilpinandLaganPaper.pdf
(5). ALEXIADOU, K. & DOUPIS, J. 2012. Management of Diabetic Foot Ulcers. Diabetes
Therapy [online]. 3 (1). [viewed 22 October 2015]. Available from:
(6). LIPSKY, B.A. & BERENDT, A.R. 2010. Hyperbaric Oxygen Therapy for Diabetic Foot
Wounds. Diabetes Care [online]. 33 (5), pp. 1143-1145. [viewed 22 October 2015].
Available from: http://care.diabetesjournals.org/content/33/5/1143.long
(7). GUFFANTI, A. 2014. Negative pressure wound therapy in the treatment of diabetic foot
ulcers: a systematic review of the literature. Journal of Wound Ostomy & Continence Nursing
[online]. 41 (3), pp. 233-237. [viewed 22 October 2015]. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/24805174
(8). CHEN, C-P., HUNG, W. & LIN, S-H. 2014. Effectiveness of hyaluronic acid for treating
diabetic foot: a systematic review and meta-analysis. Dermatologic Therapy [online]. 27, pp.
331-336. [viewed 22 October 2015]. Available from:
http://onlinelibrary.wiley.com/doi/10.1111/dth.12153/pdf

Page | 44
(9). PUNCHARD, N.A., WHELAN, C.J. & ADCOCK, I. 2004. The Journal of Inflammation.
Journal of Inflammation: London England [online]. 1 (1). [viewed 22 October 2015].
Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1074343/
(10). BHARARA, M., SCHOESS, J. & ARMSTRONG, D.G. 2010. Wound Inflammatory
Index: A “Proof of Concept” Study to Assess Wound Healing Trajectory. Journal of Diabetes
Science and Technology [online]. 4 (4), pp. 773-779. [viewed 22 October 2015]. Available
from:
http://su3pq4eq3l.search.serialssolutions.com/?genre=article&issn=19322968&title=Journal
%20Of%20Diabetes%20Science%20And%20Technology&volume=4&issue=4&date=20100
701&atitle=Wound%20inflammatory%20index%3A%20a%20%22proof%20of%20concept
%22%20study%20to%20assess%20wound%20healing%20trajectory.&spage=773&pages=7
73-9&sid=EBSCO:MEDLINE&au=Bharara%20M
(11). LAVERY, L.A. & ARMSTRONG, D.G. 2007. Temperature Monitoring to Assess,
Predict and Prevent Diabetic Foot Complications. Current Diabetes Reports [online]. 7 (6),
pp. 416-419. [viewed 22 October 2015]. Available from:
http://su3pq4eq3l.search.serialssolutions.com/?genre=article&issn=15344827&title=Current
%20Diabetes%20Reports&volume=7&issue=6&date=20071201&atitle=Temperature%20mo
nitoring%20to%20assess%2C%20predict%2C%20and%20prevent%20diabetic%20foot%20c
omplications.&spage=416&pages=416-9&sid=EBSCO:MEDLINE&au=Lavery%20LA

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Appendix 2: Evidence of Databases Searched [AMED, CINAHL, Health Source, MEDLINE]

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Appendix 2 cont: [Cochrane Library]

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Appendix 2 cont: [ProQuest]

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Appendix 2 cont: [Web of Science]

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Appendix 3a: SIGN Classifying Study Design for Methodological Appraisal (SIGN, 2015a)

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Appendix 3b: SIGN Methodological Appraisal Checklist for RCTs (SIGN, 2015b)

Page | 51
Appendix 3c: SIGN Guidance Notes for Methodological Appraisal Checklist for RCTs
(SIGN, 2015b)

Page | 52

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Appendix 3d: SIGN Grading System (SIGN, 2015c)

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Appendix 3e: SIGN Methodological Appraisal of All Studies Checklist [adapted from appendix 3b]
Study Identification Lavery et al (2004) Lavery et al (2007) Armstrong et al
(2007)
Skafjeld et al (2015)
Section 1: Internal Validity
1.1 Appropriate and clearly focused question? Yes Yes Yes Yes
1.2 Random assignment of groups? Cannot say Yes Yes Yes
1.3 Adequate concealment method used? No Yes Cannot Say No
1.4 Does the study keep subjects and
investigators blind about treatment
allocation?
Yes Yes Yes Yes
1.5 Are the treatment and control groups similar
at the start of the trial?
Yes Yes Yes Yes
1.6 Is the only difference between groups the
treatment under investigation?
Yes Yes Yes Yes
1.7 Are all relevant outcomes measured in a
standard, valid and reliable way?
Cannot say Yes No Yes
1.8 What percentage of individuals or clusters
recruited into each treatment arm of the study
dropped out before the study was completed?
Intervention: 9.09%
Control: 7.31%
Intervention:
16.94%
Structured: 10.71%
Control: 10.34%
Intervention: not
given
Control: not given
Intervention: 14.28%
Control: 0%
1.9 All of the subjects are analysed in the groups
to which they were randomly allocated
(intention to treat analysis)?
Yes Yes Cannot say Yes
1.10 Where the study is carried out at more than
one site, results are comparable for all sites?
Cannot say Cannot say Cannot say Not applicable

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Section 2: Overall Assessment of the Studies
2.1 Taking into
account clinical
considerations,
your evaluations of
the methodology
used, and the
statistical power of
the study, are you
certain the overall
effect is due to the
study intervention?
Uncertain – poor
methodological rigour and
reporting of important aspects.
Small sample size with no
justification – possibly may be
underpowered. However this
study has an extremely positive
aspect which differentiates it
compared to the other studies.
Graphs highlighting temperature
differences between the only
subject who ulcerated and a
subject who did not ulcerate
were provided. It can clearly be
seen that the patient who
ulcerated, temperature
differences between right and
left sites were more erratic and
continually presented with
higher temperatures over a
period of time at the site of
ulceration – highlights
predictive aspect of study.
Yes - good methodological
rigour and most in-depth
reporting of study information.
Large sample size and
justification given – may have
good power. Clinically,
interventions thoroughly detailed
– good grounds for repeatability.
Addition of third treatment arm
did not impact the results
significantly, was similar to the
control and therefore strengthens
the difference identified between
the intervention and control
groups.
No – poor methodological rigour
and author reporting of important
aspects of the study, possible bias
more evident. Largest sample size
is a positive aspect,grounds for
good power – 225 subjects were
randomised, however no
information regarding allocation
group size or drop outs. Some
sample size justification - suggested
a sample size of 70 per group
although 225 subjects were
randomised? Interpretation of this
study is confusing and difficult
when analysing study results.
Intervention protocols most similar
to Lavery et al (2004) and as such
these studies are more comparable.
Uncertain – Author reporting and
methodological rigour was
adequate,evidence of possible but
low bias. Smallest sample size with
no justification suggests study may
be underpowered, although study is
a pilot. In addition of theory based
counselling alongside infrared
thermometry in the intervention
makes it difficult to distinguish
results. Could the theory based
counselling actually have impacted
the results negatively? As this was
the only study not to show
statistically supportive results
regarding temperature monitoring?
Also this aspect makes the study
less comparable to the other three
studies.
2.2 Are the results of
the study directly
applicable to the
patient group
targeted?
Patient Group Targeted
 Diabetics at high risk of
lower extremity
complications
 Yes,subjects recruited from
a high risk clinic
 Diabetics classified as high
risk for lower extremity
complications
 Yes
 Diabetics classified as high risk
for lower extremity
complications
 No, limited generalisability - all
participants were recruited from
a veteran’s health centre
therefore only US Veterans
included. This population may
 High risk diabetic patients of
European Caucasian ethnic
origin
 Yes,all patients studied were
Caucasian and recruited from 6
clinics and 1 podiatrist in Oslo,
Norway.

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be of poorer health or have
significant mental ill health e.g.
increased incidence of post-
traumatic stress disorder or
depression.
2.3 Summarise the
authors’
conclusions. Add
any comments of
own assessment
and any areas of
uncertainty.
Author’s Conclusions:
Intervention group (infrared
thermometry + standard therapy)
experienced significantly fewer
diabetic foot complications
compared to control to control
(standard therapy). Results
suggest temperature monitoring
may be an effective tool to
prevent diabetic foot ulceration
Author’s Conclusions:
Intervention group (infrared
thermometry + standard therapy)
had significantly fewer ulcers
than both structured group
(structured foot exam + standard
therapy) and control group
(standard therapy). Results show
infrared thermometry can serve
as an easy to use adjunctive early
warning system to prevent
diabetic foot ulceration.
Author’s Conclusions: Intervention
group (infrared thermometry +
standard therapy) experienced
statistically significant fewer ulcers
than the control group (standard
therapy). Increased temperatures
seem to predict areas of ulceration
and self-temperature monitoring
may reduce the risk of diabetic foot
ulceration.
Author’s Conclusions: Intervention
group (infrared thermometry +
theory based counselling + standard
therapy) did not show statistically
significant results compared to
control group (standard therapy).
2.4 How well was the
study done to
minimise bias?
Low Quality (1-)
-high risk of bias
High Quality (1++)
-very low risk of bias
Low Quality (1-)
-high risk of bias
Acceptable Quality (1+)
-low risk of bias
SIGN
Grading
Recommendation: Offer temperature monitoring devices such as infrared
thermometers when recommending and creating management plans to prevent
ulceration.
B
*Note: Initially this appraisal checklist was conducted without the accompanying notes (appendix 3c); answers were inconsistent and based solely on the assumptions of set
standard questions and set answers with little clarity - as such some different results were obtained whereby two of the studies were graded a higher quality (Lavery et al, 2004 and
Armstrong et al, 2007). Following identification of the assistant notes, the checklist was repeated and found different (the current) outcomes. Lavery et al (2007) and Skafjeld et al
(2015) were unchanged from the first time (high quality and acceptable quality respectively); however the other two studies which were previously of acceptable quality were
downgraded to low quality. This will impact the review outcome.

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Appendix 4: Literature Review Tables
1.Bibliographi
c citation and
Title
Stud
y
type
Number
of
Patients
Patient
characteristics
Intervention Study Methods Length of
follow up
Outcome
measures
Statistical
Analysis
Lavery, L. A.,
Higgins, K. R.,
Lanctot, D. R.,
Constantinides,
G. P., Zamorano,
R. G., Armstrong,
D. G., et al. 2004.
“Home
monitoring of foot
skin temperature
to prevent
ulceration”
RCT 85
Standard
Therapy =
44 (3 drop
outs) – 41
completed
study.
Enhanced
Therapy =
41 (4 drop
outs) – 37
completed
study.
Participants = adults
(18-80).
Mean values:
Standard Therapy
 Age = 54.8
 % Men = 52.3
 Diabetes duration
=12.7 years
 Amputation
History = 1
 Risk category
mean = 2.41
Enhanced
Therapy
 Age = 55
 % Men = 48.8
 Diabetes duration
= 14.8
 Amputation
history = 1
 Risk category
mean = 2.41
2 Treatment Groups:
Group 1: Standard Therapy -
i.i. Therapeuticfootwear
ii. Diabetic foot education
iii. Every 10-12 weeks received a foot evaluation
conducted by a podiatrist.
Group 2: Enhanced Therapy –
Standard therapy (i,ii,iii)
+
Enhanced Therapy - Provided with a handheld
infrared skin thermometer (TempTouch) –
recorded in a log book.
-Temperaturemonitoring of both feet on plantar
aspect at 6 sites (hallux, 1st
, 3rd
& 5th
met heads,
central mid foot and heel)
-A difference of 2.2 degrees celcius between one
foot and thecontralateral foot indicated subjects
has to contact a study nurseand reduce number of
stopes carried out until thetemperature difference
Pre study neurological assessment
conducted using vibratory perception
threshold (VPT) to identify sensory
neuropathy. VPT >25V defined presence
of neuropathy.
Pre study vascular assessment included
palpation of pedal pulses, both dorsalis
pedis and posterior tibial. If one or both
pulses were not palpablethen the subject
was excluded.
Patients were enrolled if they had:
- Diabetes (does not statetypeof
diabetes included or %).
-met the high risk profile for the
development of a diabetic foot ulcer.
High risk was defined as having diabetes,
a history of foot ulceration or lower limb
amputation, presence of peripheral
sensory neuropathy with loss of
protectivesensation, evidence of a foot
deformity – this is previously identified
risk factors for foot ulcers/amputations.
Inclusion Criteria:
-World Health Organisation (WHO)
6 months
-
Measurement
s evaluated at
baseline and
again at the
end of the
study.
Primary Outcome =
foot complications
e.g. incidence of
foot ulceration.
Infection, charcot
foot and amputation
(additional but not
priority outcomes).
Secondary Outcome
= Functional
impairment –
measured via short
form health survey
(SF-36) pre and post
study.
For all analysis a
significance level of
α = 0.05 (intention to
treat basis).
Analysis of Variance
(ANOVA) was used
to evaluate
continuous variables
between the treatment
groups.
Fisher’s exact test
was used to evaluate
dichotomous
variables – an odds
ratio of 95%
confidence interval
(CI).

Page | 58
was reduced.
-Monitoring of foot in the morning and evening
-If an area had been amputated then an adjacent
area was used for measurement
-If a site had callus it was still used as a site for
monitoring.
criteria for diagnosis of Diabetes.
-Must beable to give informed consent
-Adults aged 18-80.
-Diabetic foot risk classification system
determined by International Diabetic
Working Group:participants must be
group 2 or 3.
Exclusion Criteria:
-Presence of open wounds
-Open amputation sites
-Active charcot Arthropathy
-Peripheral vascular disease
-active foot infection
-dementia
-impaired cognitive function
-history of alcohol or drug abuse within
the previous year.
General comments:
Aim: Evaluate how effective an at home infrared temperature toolwas to improve clinical outcome and functional status of diabetics with high risk feet and whether it was a useful early warning toolof inflammation and
tissueinjury possibly leading foot complications.
Results:enhanced therapy group had fewer diabetic complications (1 ulcer) compared to 7 ulcers, 2 incidents of charcot foot and 2 incidents of foot infection which required amputation in the standard therapy group – this
was statistically significant P=0.01. Patients in standard therapy group were more likely to develop a foot complication compared to the enhanced therapy group by 10.3% (95% CI 1.2-8.3). Secondary outcome of functional
status (measured by SF-36) showed no statistical difference in scores from baseline to theend of thestudy or between groups.
Study Methods: Patient characteristics were similar at baseline (no statistical significance). Good sample size (85) – 78 completed study - totalof 7 drop outs which were voluntary but no further explanation given. No
justification of sample size. Randomisation mentioned to theallocation of 2 groups: numbers randomised into each group given. However no mention as to how randomisation was carried out. Blinding mentioned – single
blind study (treatingphysician was blinded to allocation throughout course of study) – unfeasible to blind participants due to manual use of temperaturetool etc and explained it would have been unethical to conduct sham
treatment. Adequate length of follow up but relatively short compared to other studies. Recruitment of participants mentioned – from high risk diabetic foot clinics at theuniversity of Texas health centre – single centre trial.
Inclusion and exclusion criteria mentioned – ability to provideinformed consent was mentioned as a prerequisitefor inclusion however there was no further mention if informed consent was actually obtained. Absence of one
or both pedal pulses via palpation was classified as an exclusion criterion – lack of palpablepedal pulses is not solely indicative of peripheralarterial disease. Primary outcome of foot complications e.g. foot ulceration,
infection and charcot arthropathy – no mention as to definition/classification of ulceration e.g. a foot ulcer as measured by Wagner/Texas classification – therefore what they classify as an ulcer, other studies may not.
Approvalfrom ethics committee not mentioned. Good use of visual graph showing daily temperaturemeasurements in a patient that did not ulcerate compared to a patient who did. Limitations of study mentioned e.g. longer
follow up would be preferred and that the outcomes shown may be as a result of increased vigilance/ increased foot inspection in thoseusing the physicaltemperaturemonitoring device. Suggestions regarding futurestudies

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made e.g. consider randomising to a 3rd
patient group involving active screening.
Intervention Detail: standard therapy procedurenot explained in detail – what did the diabetic foot education consist of? What typeof footwear and insoles were issued - did each participant receive standard
footwear/insoles or were they customised? Did patients record how long they woreshoes for daily? Interventions of footwear, diabetic foot education and use of temperature monitoring tool relies on patient compliance.
Recording of measurements in logbook relies on participant honesty. Explanation of how temperaturemonitoring tool works not given.

Page | 60
2.Bibliographic
citation and
Title
Study
type
Number of
Patients
Patient
characteristics
Intervention Study
Methods
Length
of
follow
up
Outcome
measures
Statistical Analysis
Lavery, L. A.,
Higgins, K. R.,
Lanctot, D. R.,
Constantinides,
G. P., Zamorano,
R. G.,
Athanasiou, K.
A., et al. 2007.
“Preventing
diabetic foot
ulcerrecurrence
in high risk
patients”
RCT 173
Standard
Therapy = 58
- 52
completed
study
6 drops outs:
-3 from
adverse
events
-3 voluntary
drop out
Structured
Foot
Examination
Therapy = 56
– 50
completed
study
6 drop outs:
-4 from
adverse
events
-2 voluntary
drop outs
Enhanced
Therapy = 59
– 49
completed
study
10 drop outs:
-4 from
adverse
events
-6 voluntary
Participants = adults (18-
80)
Mean values:
Standard Therapy
 Age = 65
 % Men = 53.4
 Type2 Diabetes = 56
 Diabetes duration =
13.7
 Amputation history =
18
Structured Foot
Examination
 Age = 64.2
 % Men = 51.7
 Type2 diabetes = 53
13.8
14
Enhanced Therapy
 Age = 65.4
 % Men = 55.9
 Type2 diabetes = 55
13.7
13
3 Treatment Groups:
A pedometer was issued to all study participants to
record their daily activity in a log book.
Group 1: Standard Therapy –
i.Lower limb examination every 8 weeks
ii.Patient education program via videotape addressing
aetiology of diabetic foot ulcers, therisk factors, safe
self-care practices and what early warning signs to look
for.
iii. Therapeuticinsoles and footwear which were
regularly evaluated by a podiatrist to assess whether any
needed to be replaced/repaired.
Regular foot inspection was advised and if any areas of
concern were identified then they were to contact the
study nursewho contacted theinvestigator without
revealing treatment group assignment.
Group 2: Structured Foot Examination –
Standard Therapy (i,ii,iii)
+
Structured Foot Examination – trained to be able to
carry out a foot examination twice daily using a mirror
to visualise difficult viewing areas of the foot e.g.
plantar aspect.
Objective was to identify any redness, discolouration,
warmth by palpation.
Recording of normal and abnormal observations was
conducted in a log book (to providea protocolfor
evaluation) with the additional of picture
representations.
A self-examination checklist had to be completed to
Neurological
assessment
conducted using
VPT and 10g
monofilament
testing – number
of sites with
reduced sensation
out of 10.
Vascular
assessment
included
palpation of pedal
pulses, using the
Doppler and
ABPI.
Inclusion
Criteria:
-Diagnosis of
diabetes
-Ability to
provide informed
consent
-Adults aged 18-
80
-A history of foot
ulceration
-ABPI > 0.70
Exclusion
Criteria:
-Open wound
-Open amputation
-Active charcot
arthropathy
-Severe
15 months Primary Outcome =
presence of foot
ulceration – used
pre-established
criteria to measure
this.
Secondary Outcome
= daily use of
prescribed shoes
and insoles –
measured using a
self-reported
questionnaire at the
end of the study –
ordinal scale to
identify level of use
e.g. <4 hours daily
etc.
For all analyses a significant
level of α = 0.05. Last
observation carried forward
(LOCF) was used in an
intent to treat basis.
Analysis of Variance
(ANOVA) for independent
samples was used for
between-group comparisons
on continuous type
variables.
-an odds ratio with 95% CI.
Comparison of thetime to
develop a foot ulcer in
relation to treatment group –
a Kaplan-Meier survival
analysis was used.
3 statisticaltests were used
to investigate whether the
treatment groups were
different
-an overall test
-pairwise comparison
-test for trend
A log rank test was used in
the analysis
Based on the cell counts of
ulcer status compared to the
treatment, a Pearson χ2
statisticwas used.

Page | 61
drop outs ensure all elements of the foot examination were
conducted.
Advised to contact study nurseof any abnormal
observations.
Group 3: Enhanced Therapy –
Standard therapy (i,ii,iii)
+
Enhanced Therapy – trained to use a digital infrared
thermometer (TempTouch). A standardised videotape
was used to train each participant, followed by
participant demonstration back to the study nurseon
how to use the thermometer correctly. Recorded foot
temperatures in a logbook with pictorial representations.
-Temperaturemonitoring of both feet on the plantar
aspect at 6 sites (Hallux, 1st
, 3rd
& 5th
met heads,
midfoot and the heel)
- If an area had been amputated then an adjacent area
was used for measurement.
-A difference of 2.2 degrees celcius from one foot
compared with thesame site on theother foot for >2
days then participants had to contact the study nurseand
decrease activity until the temperatures returned to
normal.
peripheral arterial
disease
-Foot infection
-Dementia
General comments:
Aim: Evaluate the effectiveness of an at home temperaturemonitoring toolto help high risk diabetics identify inflammation and areas of their feet which are proneto ulceration before an ulcer actually develops.
Results: theenhanced therapy group had significantly fewer incidences of ulceration, >4- fold decrease risk of ulcers (8.5%) - 5 ulcers. In comparison to standard therapy (29.3%) and structured therapy (30.4%) - both had 17
ulcerations each – essentially identical. Kaplan-Meier survival analysis showed that the enhanced therapy expressed a longer mean time to develop an ulcer (429.5 days) compared to standard therapy (378.5 days) and
structured therapy (377.3 days) – the overall difference between time to develop ulcers by treatment groups was statistically significant using log rank test (P=0.011). However there was no difference between thestandard and
structured therapy for time to ulcerate (P=0.910). The enhanced therapy group was statistically different from both thestandard therapy (P=0.0059) and structured therapy (P=0.0055) in time to ulceration. Thetest for trend
found the enhanced therapy group to be superior and had a statistically significant trend of survival compared to standard or structured therapy (P=0.0107). Self-reported daily use of prescribed shoes and insoles showed good
compliance in all 3 treatment groups – no statisticaldifference in participants who wore theshoes and insoles for at least 8 hours per day among treatment groups (standard therapy 89.5%, structured foot therapy 73.2% and

Page | 62
enhanced therapy 83.0%), P>0.071. Participants in theenhanced therapy who werecompliant with assessing and recording foot temperatures 50% of the time were less likely to ulcerate (OR 50.0, P<0.001) which was
statistically significant. Of thosewho developed an ulcer in the enhanced therapy, 80% did not comply with temperaturemonitoring and participants who did not develop an ulcer, 92% assessed and recorded their foot
temperatures at least 50% of thetime. In thestructured therapy therewas no statisticaldifference in compliance of recording daily foot assessments in thosewho ulcerated (47.1%) and those who did not ulcerate (43.6%) –
P=0.811. Contacting of the study nursefor foot concerns was more significant in the enhanced therapy than in standard therapy (P=0.030) or structured therapy (P=0.026). In the enhanced therapy group 31 subjects (52.5%)
contacted the study nursecompared to 18 (31%) and 17 (30.4%) in the standard and structured groups respectively – however by thetime thesesubjects contacted thestudy nursea foot ulcer had already developed: 94.4% in
standard therapy and in 100% in structured foot therapy. In the enhanced therapy group, 7 subjects did not contact the study nursewhen an elevated temperaturewas identified. However, on average, based on pedometer
activity, whenever an elevated temperaturewas identified there was a 51.2% decrease in physicalactivity.
Study Methods: Patient characteristics were similar at baseline (not statistically significant). Good/large sample size (173) – 151 completed study – totalof 22 drop outs which were explained as either voluntary with reasons
given e.g. too much to do or due to adverse events with reasons given e.g. foot trauma MI etc. Justification of sample sizewas given and explained – was calculated on thebasis of the amount of subjects expected to ulcerate
over 15 months. Planned to have 60 subjects in each group but have 55 subjects complete the study in each group. Randomisation mentioned to theallocation of 3 groups: numbers given regarding allocation of randomised
into each group. Process of randomisation details given – via computer generated list, allocation of participants to groups was then sealed in opaque envelopes to maintain concealment. Single blind study – physician blinded
(unfeasible to blind participants due to manual use of temp monitoring tooletc) – participants were instructed not to discuss their group allocation in order to help maintain blinding. Good length of follow up (15
months).Study was approved by hospitalreview board. Recruitment of participants not mentioned – where were they recruited from? – mentions it is a multicentre trial but doesn’t given any more details. Inclusion and
exclusion criteria mentioned – ability to provideinformed consent was mentioned as a prerequisitefor inclusion however there was no further mention if informed consent was actually obtained. Primary outcome of foot
ulceration which was defined using previously established criteria – University of Texas Wound Classification. No strengths or limitations of the study addressed. No suggestions about improving future studies in this research
area.
Intervention detail: Standard Therapy:no explanation of how lower extremity evaluation was carried out/what it consisted of. Patient education program explained in further detail – videotapeused to ensure standardisation.
Therapeuticfootwear and insoles mentioned – did each participant receive standard footwear/insoles? Were they customised or prefabricated? - Good that they evaluated how long patients used footwear for daily. When
patients inspected their feet did they record findings in a logbook? Daily activity was monitored by a pedometer to provide figures on how much peoplewalked – recorded in logbook. Structured Foot Exam Therapy:trained to
conduct a structured foot examination – observational only, how was this explained to participants?Did they each receive the same standard training? Recorded in a logbook with pictures for help and had to complete a
checklist of elements included in self-examination. Purposeof logbook was to providestructured evaluation and to verify that theexamination was performed. Enhanced therapy:trained use of temperaturemonitoring tool
was standardised by use of a videotape to teach participants how to correctly use it – followed by study nurseevaluating if they used it correctly. Information of how the temperaturemonitoring toolworks was given.
Interventions of patient education, therapeuticfootwear/insoles, foot inspection, structured foot examination and use of temperaturetool requires patient compliance. Recording of measurements in logbook relies on
participant honesty.

DISSERTATION Critical Review Assignment 1

DISSERTATION Critical Review Assignment 1

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