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Background The aim of this paper was to create an updated Australian guideline on footwear for people with diabetes. Methods We reviewed new footwear publications, (inter)national guidelines, and consensus expert opinion alongside the 2013 Australian footwear guideline to formulate updated recommendations. ResultWe recommend health professionals managing people with diabetes should: (1) Advise people with diabetes to wear footwear that fits, protects and accommodates the shape of their feet. (2) Advise people with diabetes to always wear socks within their footwear, in order to reduce shear and friction. (3) Educate people with diabetes, their relatives and caregivers on the importance of wearing appropriate footwear to prevent foot ulceration. (4) Instruct people with diabetes at intermediate- or high-risk of foot ulceration to obtain footwear from an appropriately trained professional to ensure it fits, protects and accommodates the shape of their feet. (5) Motivate people with diabetes at intermediate- or high-risk of foot ulceration to wear their footwear at all times, both indoors and outdoors. (6) Motivate people with diabetes at intermediate- or high-risk of foot ulceration (or their relatives and caregivers) to check their footwear, each time before wearing, to ensure that there are no foreign objects in, or penetrating, the footwear; and check their feet, each time their footwear is removed, to ensure there are no signs of abnormal pressure, trauma or ulceration. (7) For people with a foot deformity or pre-ulcerative lesion, consider prescribing medical grade footwear, which may include custom-made in-shoe orthoses or insoles. (8) For people with a healed plantar foot ulcer, prescribe medical grade footwear with custom-made in-shoe orthoses or insoles with a demonstrated plantar pressure relieving effect at high-risk areas. (9) Review prescribed footwear every three months to ensure it still fits adequately, protects, and supports the foot. (10) For people with a plantar diabetic foot ulcer, footwear is not specifically recommended for treatment; prescribe appropriate offloading devices to heal these ulcers. Conclusions This guideline contains 10 key recommendations to guide health professionals in selecting the most appropriate footwear to meet the specific foot risk needs of an individual with diabetes.
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R E S E A R C H Open Access
Diabetic Foot Australia guideline on
footwear for people with diabetes
Jaap J. van Netten
1,2,3*
, Peter A. Lazzarini
1,2,3,4
, David G. Armstrong
5
, Sicco A. Bus
6
, Robert Fitridge
2,7
,
Keith Harding
8
, Ewan Kinnear
2,4
, Matthew Malone
2,9
, Hylton B. Menz
10
, Byron M. Perrin
2,11
, Klaas Postema
12
,
Jenny Prentice
2,13
, Karl-Heinz Schott
14
and Paul R. Wraight
2,15
Abstract
Background: The aim of this paper was to create an updated Australian guideline on footwear for people with
diabetes.
Methods: We reviewed new footwear publications, (inter)national guidelines, and consensus expert opinion
alongside the 2013 Australian footwear guideline to formulate updated recommendations.
Result: We recommend health professionals managing people with diabetes should: (1) Advise people with
diabetes to wear footwear that fits, protects and accommodates the shape of their feet. (2) Advise people with
diabetes to always wear socks within their footwear, in order to reduce shear and friction. (3) Educate people with
diabetes, their relatives and caregivers on the importance of wearing appropriate footwear to prevent foot
ulceration. (4) Instruct people with diabetes at intermediate- or high-risk of foot ulceration to obtain footwear from
an appropriately trained professional to ensure it fits, protects and accommodates the shape of their feet. (5)
Motivate people with diabetes at intermediate- or high-risk of foot ulceration to wear their footwear at all times,
both indoors and outdoors. (6) Motivate people with diabetes at intermediate- or high-risk of foot ulceration (or
their relatives and caregivers) to check their footwear, each time before wearing, to ensure that there are no foreign
objects in, or penetrating, the footwear; and check their feet, each time their footwear is removed, to ensure there
are no signs of abnormal pressure, trauma or ulceration. (7) For people with a foot deformity or pre-ulcerative
lesion, consider prescribing medical grade footwear, which may include custom-made in-shoe orthoses or insoles.
(8) For people with a healed plantar foot ulcer, prescribe medical grade footwear with custom-made in-shoe
orthoses or insoles with a demonstrated plantar pressure relieving effect at high-risk areas. (9) Review prescribed
footwear every three months to ensure it still fits adequately, protects, and supports the foot. (10) For people with a
plantar diabetic foot ulcer, footwear is not specifically recommended for treatment; prescribe appropriate offloading
devices to heal these ulcers.
Conclusions: This guideline contains 10 key recommendations to guide health professionals in selecting the most
appropriate footwear to meet the specific foot risk needs of an individual with diabetes.
Keywords: Foot ulcer, Diabetes mellitus, Footwear, Prevention, Guideline
* Correspondence: jaap.vannetten@qut.edu.au
1
School of Clinical Sciences, Queensland University of Technology, Brisbane,
QLD, Australia
2
Diabetic Foot Australia, Brisbane, QLD, Australia
Full list of author information is available at the end of the article
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2
DOI 10.1186/s13047-017-0244-z
Background
Diabetic foot ulcers are a costly complication of diabetes,
reducing peoples quality of life, and increasing morbid-
ity, mortality and healthcare expenditure [14]. The an-
nual incidence of foot ulcers in people with diabetes is
approximately 2%, both globally [3] and in Australia [5],
and the lifetime risk is between 19% and 34% [6]. Add-
itionally, diabetic foot ulcers are the leading cause of lower
extremity amputations and cause approximately 2% of all
hospitalisations [35, 7, 8]. Therefore, the prevention of
diabetic foot ulcers is of paramount importance.
Diabetic foot ulcers are typically caused by repetitive
stresses (shear and pressure) on the foot in the presence
of the diabetes-related complications of peripheral
neuropathy or peripheral artery disease, and their heal-
ing is often complicated by the development of infection
[913]. Use of inappropriate footwear or walking bare-
foot typically increases the magnitude of the local mech-
anical repetitive stresses on the foot that are leading
causes of the development of diabetic foot ulceration
[912]. Thus, it is recommended that people with
diabetes wear appropriate footwear designed to reduce
repetitive stresses at all times, to help prevent diabetic
foot ulceration [14, 15].
In 2013, the Australian Diabetes Foot Network pub-
lished one of the first nationwide practical guidelines on
the provision of footwear for people with diabetes [16].
Since this publication, pivotal new studies [9, 1730]
and international guidelines [10, 14, 15] have been
published on footwear for people with diabetes. This
new literature provides a stronger evidence-base for the
effectiveness of footwear in ulcer prevention for people with
diabetes, new data-driven directions for the prescription of
footwear, and new evidence on the importance of adher-
ence to wearing footwear [9, 10, 14, 15, 1730]. The aim of
this article is to update the 2013 Australian practical guide-
line [16], and thereby creating a new Diabetic Foot
Australia guideline on footwear for people with diabetes.
Methods
Procedure for developing the guideline
The Diabetic Foot Australia guideline on footwear for
people with diabetes aims to provide guidance to the
multidisciplinary healthcare professionals involved in the
provision of footwear for people with diabetes. The
Australian Diabetes Foot Network 2013 practical guide-
line on the provision of footwear [16] was used as a
baseline for the creation of this updated guideline. Infor-
mation from the 2013 footwear guideline was updated
first by the primary author after reviewing and incorpor-
ating any new footwear-related recommendations from
the most recent Australian National Health and Medical
Research Council (NHMRC) diabetic foot guideline [31]
and the International Working Group on the Diabetic
Foot (IWGDF) guidance documents [10, 14, 15]. The
primary author then reviewed and incorporated com-
mon findings from all recent systematic reviews on foot-
wear interventions for people with diabetes [1722],
recent randomized controlled trials included in these re-
views [23, 24], and finally any further studies obtained
from hand searching reference lists of these articles
and an additional non-systematic search of the litera-
ture [9, 2530]. After collating all findings, three ta-
bles and one figure were created describing footwear
requirements and offloading effects of footwear modi-
fications to prevent diabetic foot ulceration, based on
published literature [10, 15, 16, 3234] and expert
opinion. Furthermore, to ensure a common and clear
vocabulary between all the different multidisciplinary
healthcare professionals involved in the provision of
footwear for people with diabetes [14, 31], a table of
definitions for common terms related to footwear for
people with diabetes was developed based on litera-
ture [15, 16, 32, 33] and expert opinion (Table 1).
The first draft of this guideline was written by the first
author (JvN), and then sent to two co-authors (PAL and
PW) for critical review and expert opinion. A second
draft incorporating consensus feedback from the three
authors was sent to all authors for critical review and ex-
pert opinion feedback. The authors of this guideline, all
(inter)national experts in the field of diabetic foot ulcer
and footwear management, came from the following
backgrounds: podiatric medicine (n= 5), podiatric sur-
gery (n= 1), human movement science (n= 2), wound
medicine (n= 2), pedorthics (n= 1), rehabilitation medi-
cine (n= 1), endocrinology (n= 1), and vascular surgery
(n= 1). A third draft incorporating feedback from all co-
authors was written by the first author (JvN) and again
sent to all co-authors for review. This process was re-
peated one more time, until consensus was reached from
all authors, leading to the final version of the guideline,
approved by all authors.
Definitions for foot risk status
The purchase and wearing of appropriate footwear is an
important process of care for all individuals with dia-
betes. This importance increases as the individuals risk
for developing a foot ulcer increases. Different classifica-
tions for foot risk status are used worldwide. For the
purpose of this Australian footwear guideline we
followed the classification provided in the Australian
NHMRC guideline [31]:
(i) Low-risk of foot ulceration: people with no
identifiable risk factors on foot screening (no
peripheral neuropathy, peripheral artery disease,
foot deformity, previous foot ulcer, or history of
lower-extremity amputation).
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 2 of 14
Table 1 List of definitions related to footwear for people with diabetes
Term Definition
Abnormal foot shape A foot shape that cannot be accommodated in pre-fabricated footwear. This includes, but is not limited to,
feet with: hallux valgus, clawed/hammer toes, severe pes-planus or cavus foot type, abnormally wide feet,
flat foot, minor amputation or Charcot foot.
Bespoke footwear Synonym for Custom-made medical grade footwear.
Custom-made footwear Synonym for Custom-made medical grade footwear.
Custom-made insole An insole that is custom-made to the individuals foot using a 2D or 3D impression of the foot, and that is
often built-up in a multi-layer construction. This may also incorporate other features, such as a metatarsal
pad or metatarsal bar. The insole is designed to conform to the shape of the foot, providing cushioning
and redistribution of plantar pressure.
Custom-made medical grade footwear Footwear uniquely manufactured for one person, when this person cannot be safely accommodated in
pre-fabricated medical grade footwear. It is made to accommodate deformity and relieve pressure over
at-risk sites on the plantar and dorsal surfaces of the foot. In-depth assessment, multiple measurements,
impressions or a mould, and a positive model of a persons foot and ankle are generally required for
manufacture.
Customised insole Term to denote a pre-fabricated insole to which minor modifications specific to a persons foot may
have been made. This term is not synonymous with Custom-made insole.
Depth-inlay footwear Synonym for Extra-depth footwear.
Depth footwear Synonym for Extra-depth footwear.
Extra-depth footwear Footwear constructed with additional depth and volume in order to accommodate deformity such as
claw/hammer toes and/or to allow for space for a thick insole. Usually a minimum of 5 mm (~3/16)
depth is added compared to pre-fabricated footwear. Even greater depth is sometimes provided in
footwear that is referred to as double depth or super extra-depth.
Footwear modification Modification to existing footwear with an intended therapeutic effect, e.g. pressure relief.
In-shoe orthosis/orthotic Term used for device put inside the shoe to achieve pressure reduction or alteration in the function
of the foot. Can be pre-fabricated or custom-made.
Liner Synonym for insole.
Medical grade footwear Footwear that meets the specific needs of a person. Can be either pre-fabricated (see Pre-fabricated
medical grade footwear) or custom-made (see Custom-made medical grade footwear).
Metatarsal pad Small pad placed proximal to the metatarsal head to relieve focal pressure and transfer load more
proximally.
Metatarsal bar Bar extending across part of or the entire forefoot placed proximal to the metatarsal heads to relieve
focal pressures and transfer load more proximally.
Off-the-shelf footwear Readily available footwear that has not been modified and has no intended therapeutic functions.
Orthopaedic footwear Synonym for Custom-made medical grade footwear.
Pedorthic footwear Synonym for Medical grade footwear. Can be either pre-fabricated (in that case synonym for
Pre-fabricated medical grade footwear) or custom-made (in that case synonym for Custom-made
medical grade footwear).
Pedorthic footwear modification Synonym for Footwear modification.
Pre-fabricated medical grade footwear Pre-fabricated footwear that meets the specific needs of a person, on the basis of footwear that
provides extra depth, multiple width fittings and features designed to accommodate a broader
range of foot types. Other features may include modified soles, fastenings and smooth internal linings.
This type of footwear is usually available at specialty shoe shops.
Pre-fabricated insole An off-the-shelfflat or contoured insole made without reference to the shape of the patients foot.
Shoe insert Synonym for insole or in-shoe orthosis.
Shoe last Last used to make footwear. The upper of the footwear is moulded or pulled over the last. The last
shape defines the footwear shape including the outsole shape, heel pitch and toe spring. For
off-the-shelf or pre-fabricated footwear generically generated lasts in different sizes are used.
Therapeutic footwear Generic term for footwear that is designed to allow some form of treatment. May refer to both
custom-made or pre-fabricated medical grade footwear.
Toe orthosis Synonym for In-shoe orthosis, but specifically for the toe.
Several healthcare disciplines may be involved in the provision of footwear for people with diabetes. Having a common vocabulary is essential for clear
communication. We propose to use the following definitions, obtained from [15,16,32,33] and authorsexpert opinion
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 3 of 14
(ii) Intermediate-risk of foot ulceration: people with only
one risk factor on foot screening (either peripheral
neuropathy, peripheral artery disease or foot
deformity) and no previous foot ulcer or amputation.
(iii) High-risk of foot ulceration: people with two or
three risk factors on foot screening (peripheral
neuropathy, peripheral artery disease or foot
deformity) or with a previous foot ulcer or
amputation.
According to the NHMRC guideline, Aboriginal and
Torres Strait Islander people with diabetes are consid-
ered to be at high-risk for foot ulceration, until the per-
sons level of risk is adequately assessed and confirmed
otherwise [31].
To determine foot risk status, all people with diabetes
should undergo at least a yearly foot screening by an ap-
propriately trained registered healthcare professional
with demonstrated competency [14, 31]. People with an
intermediate- or high-risk foot status should be screened
at least once every 3 to 6 months [14, 31]. In accordance
with the NHMRC guideline, this should consist of
screening for peripheral neuropathy (10 g monofilament
sensitivity; vibration perception; neuropathy disability
score), peripheral artery disease (palpation of peripheral
pulses; ankle-brachial pressure index; toe-brachial pres-
sure index), foot deformity (six point scale scoring small
muscle wasting, Charcot foot deformity, bony promin-
ence, prominent metatarsal head, hammer or claw toes
and limited joint mobility), and assessment of a history
of foot ulcer(s) or lower-extremity amputation [31]. The
Australian Diabetes Society has published a video-
example of such a foot examination [35].
Structure of the guideline
This guideline consists of three parts and a discussion.
Firstly, footwear recommendations and their rationale are
provided for people at-risk of foot ulceration; These rec-
ommendations apply to people at low-, intermediate- or
high-risk. Secondly, additional specific footwear recom-
mendations and their rationale are provided for people at
intermediate- or high-risk of foot ulceration. Thirdly, foot-
wear and offloading recommendations for people with a
diabetic foot ulcer are summarised. Finally, considerations
on footwear provision, on education and adherence, on
cultural and geographical differences, and on methodology
and terminology are discussed.
Results
This guideline contains 10 key recommendations to guide
health professionals managing people with diabetes choos-
ing the most appropriate footwear for the persons specific
foot risk needs (Table 2). The recommendations and their
rationale are described separately in this section.
Table 2 Recommendations on footwear for people with diabetes
# Recommendations
For all people at-risk of foot ulceration
1 Advise people with diabetes to wear footwear that fits, protects and accommodates the shape of their feet
2 Advise people with diabetes to always wear socks within their footwear, in order to reduce shear and friction
3 Educate people with diabetes, their relatives and caregivers on the importance of wearing appropriate footwear
to prevent foot ulceration
For people at intermediate- or high-risk of foot ulceration
4 Instruct people with diabetes at intermediate-or high-risk of foot ulceration to obtain footwear from an appropriately
trained professional to ensure it fits, protects and accommodates the shape of their feet
5 Motivate people with diabetes at intermediate- or high-risk of foot ulceration to wear their footwear at all times,
both indoors and outdoors
6 Motivate people with diabetes at intermediate- or high-risk of foot ulceration (or their relatives and caregivers) to
check their:
a. footwear, each time before wearing, to ensure that there are no foreign objects in the footwear, or penetrating,
the soles
b. feet, each time their footwear is removed, to ensure that there are no signs of abnormal pressure, trauma or
ulceration
7 For people with a foot deformity or pre-ulcerative lesion, consider prescribing medical grade footwear, which may
include custom-made in-shoe orthoses or insoles
8 For people with a healed plantar foot ulcer, prescribe medical grade footwear with custom-made in-shoe orthoses
or insoles with a demonstrated plantar pressure reducing effect at the high-risk areas
9 Review prescribed footwear every three months to ensure it still fits, protects, and supports the foot
For people with diabetic foot ulceration
10 For people with a plantar diabetic foot ulcer, footwear is not specifically recommended for treatment; prescribe
appropriate offloading devices to heal these ulcers
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 4 of 14
Footwear for people with diabetes at-risk of foot
ulceration
Recommendation 1:
Advise people with diabetes to wear footwear that fits,
protects and accommodates the shape of their feet.
Rationale
People with diabetes should wear footwear that fits,
protects and accommodates the shape of their feet [14]
(see Table 3 and Fig. 1). This includes having adequate
length, width, and depth (and consequently adequate
girth, i.e. adequate volume) [10, 15, 16, 32, 33]. A par-
ticular emphasis may need to be placed on the toe box
of the shoe that should be consistent with the shape of
the forefoot and toes of the person. An enclosed heel
with a stabilising heel counter is recommended. Open-
heel footwear can result in direct trauma injury to the
heel and may require a person to claw their toes in order
to keep the footwear fixed to their feet, further increas-
ing the repetitive stress under their forefoot, and in turn
the risk of ulceration. Adequate closure of the footwear
is needed, to prevent the foot from sliding forwards and
Table 3 Requirements for footwear for people with diabetes
Feature Requirements
Length Inner length of the footwear should be 12 cm longer than the foot length as measured from heel to the longest
toe when a person is standing. Adequate length needs to be confirmed when people are weight-bearing while
wearing the footwear.
Depth Depth should accommodate the toes to move freely without causing pressure at either the medial, lateral or the
dorsal side.
Width Width should equal the width of all parts of the foot. Width is good when the upper can be slightly bunched. The
relation between forefoot and hindfoot is important, as accommodating a wide forefoot may result in the heel
being too wide.
Height Footwear height can be low, ankle-high, or high. High footwear provides more firmness, stability and reduces joint
motion. The shaft of high footwear also contributes to forefoot pressure reduction. See further Table 3for specific
height requirements for people with a foot deformity.
Insole The removable moulded insole can be pre-fabricated, adjusted or custom-made. The primary function of the insole
is pressure redistribution. This is achieved via the principle of increasing the contact area between the foot and the
insole, and the addition of corrective elements in the insole. Shock-absorbing, soft but sufficiently resilient and
non-slippery materials should be used. See further Table 4for the offloading effects of specific insole modifications.
Outsole Rubber, plastic, and leather can all be used in construction of footwear outsoles, but rubber outsoles are thought to
be superior.
Outsoles can be supple, toughened or stiff. The shoe should not be more supple than the foot, or friction between
foot and shoe will develop during push-off. See further Table 3for specific outsole requirements for people with a
foot deformity and Table 4for the offloading effects of specific modifications.
Rocker profile Rocker profiles have proven effectiveness in reducing plantar pressures, especially the forefoot. The rocker profile
chosen depends on the affected joints and is determined by the apex position (pivot point) and the angle from
the pivot point to the tip of the toe. For plantar pressure reduction of the metatarsophalangeal joints, the pivot
point needs to be proximal to these joints.
The rocker profile also impacts balance; the more proximally placed, the greater the balance disturbance. A persons
balance should therefore always be taken into account when deciding on the rocker profile.
Heel enclosure An adequately fitting and enclosed heel is recommended, as open backed footwear or a heel enclosure that is too
wide can result in injury and usually requires a person to claw their toes in order to keep them on. The heel counter
needs to be free of edges protruding into the footwear.
Heel lift The heel lift (or heel-forefoot difference, or pitch) should be generally 1.52 cm, and should not exceed 3 cm.
Closure Adequate closure (or fixation) is needed to keep the foot from sliding forward. Closure should allow secure longer-term
fastening and individual adjustment. Laces have long been considered the optimal choice; however, alternatives that are
easier to use while still meeting these criteria are available as well, and innovative closures continue to be developed.
Uppers The uppers consist of the quarter(hind- and midfoot) and vamp(forefoot and toes). Uppers should be made from
leather or a combination of materials (similar to sports shoes), with smooth inner lining made from a material that
does not harden over time, with limited seams and preferably no seams in the vamp area as they reduce the ability
of the leather to give.
Uppers should be breathable and durable and have the ability to mould to deformities of the foot without resulting
in pressure areas. Uppers can be supple, toughened or stiff. The vamp area should generally remain supple to
accommodate the toes. See further Table 3for specific requirements for the uppers (quarter) for people with a foot
deformity.
Toe box The part of the shoe that covers and protects the toes. This should be supple (unless specific requirements (e.g.
for building professionals) require otherwise), and should accommodate the shape of the toes, to avoid any
rubbing on the toes.
Features and requirements in this table are based on [10,15,16,32,33] and authorsexpert opinion; features are depicted in Fig. 1
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 5 of 14
thus causing shear injury to the toes or plantar foot [36].
All features in Table 3 should be considered in combin-
ation, as their intended function is closely related and
changes to one feature may affect other features and
overall function [10, 15, 16, 32, 33].
People at low-risk of foot ulceration can usually be
safely accommodated in a wide range of off-the-shelf
footwear without specific requirements, provided the
footwear is correctly fitted and appropriate for the activ-
ity to be undertaken [10, 15, 16, 32, 33]. For people at
intermediate- or high-risk of foot ulceration, see recom-
mendations 4-9. When new footwear is provided to a
person with diabetes at low-risk of foot ulceration, ad-
vise them that a wear-inperiod may be needed where
they slowly increase the number of hours per day the
footwear is used, and that they should be extra vigilant
of their foot health in this period.
Recommendation 2:
Advise people with diabetes to always wear socks within
their footwear, in order to reduce shear and friction.
Rationale
People with diabetes should be advised to always wear
socks within their footwear, to reduce shear and friction.
Further, advise people with diabetes to wear socks made
of mostly natural materials (to prevent undue moisture
accumulation), that are seamless (to prevent undue
repetitive stresses) and do not have elasticated cuffs (to
prevent undue oedema).
Recommendation 3:
Educate people with diabetes, their relatives and care-
givers on the importance of wearing appropriate foot-
wear to prevent foot ulceration.
Rationale
People with diabetes, their relatives and caregivers should
also be educated on the importance of appropriate foot-
wear to prevent foot ulceration, and the importance of ad-
herence to wearing it [14]. Also, the importance of annual
foot screens to assess their risk of foot ulceration, and to
return for further footwear advice if their foot risk status
increases should be emphasised [14].
Footwear for people with diabetes at intermediate- or
high-risk of foot ulceration
Recommendation 4:
Instruct people with diabetes at intermediate-or high-
risk of foot ulceration to obtain footwear from an appro-
priately trained professional to ensure it fits, protects
and accommodates the shape of their feet.
Rationale
People with only one risk factor identified after foot
screening (either peripheral neuropathy, peripheral ar-
tery disease, or foot deformity) are at intermediate-
risk of foot ulceration, whereas people with two or
three risk factors (peripheral neuropathy, peripheral
artery disease or foot deformity) or with a previous
foot ulcer or amputation are at high-risk of foot
ulceration.
People who develop diabetic peripheral neuropathy
lose protective sensation and their ability to feel pressure
and pain. Thus, they may have a tendency to purchase
poorly fitting footwear in an attempt to stimulate some
sensory feedback [16, 37]. They also do not feel abnor-
mally high repetitive stress (pressure or shear) caused by
inappropriate footwear or walking barefoot and are more
likely to develop pre-ulcerative lesions (e.g. callus or blis-
ters) that subsequently lead to ulceration [9, 12]. People
with peripheral artery disease are less likely to heal pre-
Fig. 1 Footwear features. See Table 2 for a description of the requirements of these features
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 6 of 14
ulcerative lesions or minor trauma due to inadequate
perfusion, and as such need to avoid inappropriate foot-
wear that may cause these situations. A foot deformity
changes foot biomechanics and may lead to abnor-
mally high repetitive stresses; high plantar pressure in
particular increases the risk of foot ulceration and
therefore needs to be accommodated. People with a
previous foot ulcer are at high-risk of developing a
new ulcer, with reported re-ulceration rates of 40
50% within the first 12 months after healing [6, 38].
Due to the high re-ulceration rates it is recommended
that the term diabetic foot remissionis used with
patients whose ulcer has healed, to highlight the
need for ongoing vigilance to prevent ulcer recur-
rence [6, 3941].
All people at intermediate- or high-risk of foot ul-
ceration should be instructed to wear footwear that
fits, protects and accommodates the shape of their
foot (Table 3 and Fig. 1). Due to the complexities in
accommodating the foot and the importance of pre-
venting foot ulceration, people with diabetes should
be instructed to obtain their footwear from an appro-
priately trained professional with demonstrated com-
petencies in footwear fitting for this population, to
ensure the footwear meets all requirements.
Recommendation 5:
Motivate people with diabetes at intermediate- or high-
risk of foot ulceration to wear their footwear at all times,
both indoors and outdoors.
Rationale
Because of their increased risk, people with diabetes at
intermediate- or high-risk of foot ulceration should be
motivated to wear their footwear at all times, both
indoors and outdoors. When doing so, be aware that
adherence to wearing footwear is significantly lower in-
doors compared to outdoors [30], while the majority of
steps in these patient groups have been shown to be
taken indoors [30, 42]. Depending on cultural prefer-
ence, prescribing suitable footwear for outdoors and a
second pair for indoors may be advisable. The indoor
footwear should meet the same requirements with re-
gard to adequacy of fit and offloading, but compromises
might be made in the materials used in manufacture, as
it is likely to experience less wear-and-tearcompared
to footwear used outdoor. See further the considerations
on education and adherence.
Recommendation 6:
Motivate people with diabetes at intermediate- or high-
risk of foot ulceration (or their relatives and caregivers)
to check their:
a. footwear, each time before wearing, to ensure that
there are no foreign objects in the footwear or
penetrating the soles.
b. feet, each time their footwear is removed, to ensure
that there are no signs of abnormal pressure, trauma
or ulceration.
Rationale
People with peripheral neuropathy have lost the abil-
ity to feel pressure, pain or foreign objects. They, or
their relatives and caregivers, need to be motivated to
check their footwear each time before they are put
on, to ensure that there are no foreign objects in the
footwear or penetrating the soles. Furthermore, they
should also check their feet each time their footwear
is removed, to ensure that there are no signs of ab-
normal pressure, shear, trauma or ulceration. People
should be advised to immediately seek help from an
appropriately trained professional when their footwear
is damaged or when signs of abnormal pressure,
shear, trauma or ulceration on their feet are found.
Recommendation 7:
For people with a foot deformity or pre-ulcerative lesion,
consider prescribing medical grade footwear, which may
include custom-made in-shoe orthoses or insoles.
Rationale
When a foot deformity, pre-ulcerative lesion is present,
off-the-shelf footwear is not likely to be appropriate.
Prescribing medical grade footwear (pre-fabricated or
custom-made; Table 1) needs to be considered, to
accommodate the altered biomechanics. This medical-
grade footwear may also include custom-made in-shoe
orthoses or insoles. Depending on the foot deformity
present or the location of the pre-ulcerative lesion, the
footwear requirements algorithms for prescription
(Table 4) and footwear modifications (Table 5) should be
followed [25, 33]. The outsole, uppers and tongue can be
supple,toughened, and stiff[33]. Toughened or
stiff features facilitate the even distribution of forces
exerted on the foot; unfortunately, no measurable defin-
ition of these is available [33].
Recommendation 8:
For people with a healed plantar foot ulcer, prescribe
medical grade footwear with custom-made in-shoe orth-
oses or insoles with a demonstrated plantar pressure re-
lieving effect at the high-risk areas.
Rationale
For people with a healed plantar foot ulcer, off-the-shelf
footwear is most unlikely to be sufficient. Medical grade
footwear (pre-fabricated or custom-made; Table 1) with
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 7 of 14
a demonstrated plantar pressure reducing effect at high-
risk areas, including the previous ulcer location, needs
to be prescribed. This medical-grade footwear should
also include prescribed custom-made in-shoe orthoses
or insoles to increase the plantar pressure reducing ef-
fect. Based on two recent randomised controlled trials,
ademonstrated plantar pressure reducing effect(com-
bined effect of the new medical grade footwear with
orthosis or insole) is defined as a > 30% reduction at the
area of the highest plantar pressure in comparison to
thesameareainthepatientscurrentfootwear,ora
level below 200 kPa if measured with a validated and
calibrated system with a sensor area of 1 cm
2
[23, 24].
When such footwear is being worn by patients, the risk
of re-ulceration is smaller [23]. Again depending on the
location of the previous ulcer and presence (or absence)
of a foot deformity and high-risk areas, follow the
footwear requirements algorithms for prescription
(Table 4) and footwear modifications (Table 5), with
additional options provided by orthoses [25, 33]. The
recommendation of prescribing footwear with a
demonstrated plantar pressure reducing effect is in
line with strong recommendations from the IWGDF
guidelines [15], but has yet to be implemented
widely in clinical practice in Australia. Different
systems with different validity and reliability are
available to quantify in-shoe plantar pressure [43].
We encourage services to invest in regular plantar
Table 5 Plantar pressure reducing offloading effects of insole and footwear modifications
Region of interest Hal-
lux
Toes
2-3
Toes
4-5
MTH
1
MTH
2-3
MTH
4-5
Mid-
foot
med.
Mid-
foot
lat.
Accommodative insole modifications
1. Replacement of top cover b
2. Local removal of material
3. Local cushioning
Corrective insole modifications
4. Addition of a metatarsal pad
5. Addition of a trans-metatarsal bar
6. Repositioning of metatarsal pad or bar
7. Addition of a medial arch support
8. Adjustment of pivot point of insole
Outsole modification
9. Adjustment of pivot point of outsole
Combined modifications
1 + 2
1 + 3
1 + 4
1 + 5
1 + 6
Legend:
>20% pressure reduction a10-20% pressure reduction a0-10% pressure reduction a
Med. medial, Lat. lateral. This table is based on [25]
For the blank cells in the matrix, there is either not enough information available, or pressure reduction was not statistically significant, or pressure increased;
these modifications are therefore not recommended for these regions of interest
a
Pressure reduction was significantly different from 0 (p-values < .05)
b
Replacement with a new top cover of the same material
Table 4 Specific footwear requirements for people with diabetes and a foot deformity
Height Outsole Uppers (quarter)
b
Tongue
Limited joint mobility Low
a
Toughened Supple Supple
Pes cavus Ankle-high Toughened Toughened Toughened
c
Flexible flat foot with hallux valgus High Toughened Toughened Toughened
c
Rigid flat foot with hallux valgus Ankle-high Toughened Strong medial support Toughened
c
Charcot foot High Stiff Toughened Toughened
c
Hallux or toe amputation High Stiff Toughened Toughened
c
Forefoot amputation High Stiff Stiff Stiff
This table is based on [33]
a
Unless a person has limited joint mobility in the ankle joint, in that case use ankle-high or high footwear
b
The uppers consist of quarter and vamp, the requirements here concern the quarters, as the vamp typically needs to remain supple to accommodate the toes
(see further Table 2)
c
When a tongue is toughened, it should be padded as well
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 8 of 14
pressure measurement protocols in daily clinical
practice for people with diabetes and a healed
plantar foot ulcer, and implementing the algorithms
outlined in Tables 4 and 5.
Recommendation 9:
Review prescribed footwear every three months to en-
sure it still fits, protects, and supports the foot.
Rationale
Both the foot and the footwear change shape over time.
Prescribed footwear, and custom-made orthoses or in-
soles, should be reviewed every three months to ensure
it still fits, protects and supports the foot. This three-
month interval is recommended based on the rando-
mised controlled trial by Bus and colleagues, who used a
three-month interval to ensure prescribed footwear
remained appropriate, on expert opinion from seeing
wear and tear in footwear in daily clinical practice, and
aligns with the regular foot-screening interval for people
at intermediate- or high-risk of foot ulceration as recom-
mended in the NHMRC guideline [23, 31]. For people
with a healed plantar foot ulcer who have been pre-
scribed medical grade footwear with a demonstrated
plantar pressure relieving effect, this effect still needs to
be present for the footwear to be considered appropriate.
Based on the findings from the trial by Bus and col-
leagues [23], ongoing research into its implementation
in daily clinical practice and expert opinion, we suggest
a three- to six-month interval for reviewing and demon-
strating the plantar pressure relieving effect with vali-
dated equipment.
Footwear for people with diabetic foot ulceration
Recommendation 10:
For people with a plantar diabetic foot ulcer, footwear is
not specifically recommended for treatment; prescribe
appropriate offloading devices to heal these ulcers.
Rationale
Footwear is not specifically recommended to treat a
plantar diabetic foot ulcer in the IWGDF guidelines; in
contrast offloading devices are recommended and neces-
sary to heal these ulcers [15, 31]. We strongly recom-
mend that any health professional treating a patient with
a plantar diabetic foot ulcer ensures their patient has an
appropriate offloading device. The most strongly recom-
mended devices in the NHMRC guideline and IWGDF
guidance documents are non-removable knee-high de-
vices, such as a total contact cast or removable cast walker
made irremovable [15, 31]. Only when knee-high devices
are contraindicated or not tolerated by people with a dia-
betic foot ulcer should other offloading devices (such as
forefoot offloading shoes and cast shoes), and lastly
custom-made temporary footwear be considered [15].
Footwear for the unaffected foot of a person with a
diabetic foot ulcer should follow the recommendations
and criteria applied to people at high-risk of foot ulcer-
ation. Additionally, any height-difference caused by an
offloading device may need to be corrected by adjusting
the footwear of the unaffected leg. This can be achieved
with internal footwear modifications or with external de-
vices that are applied to the bottom of the shoe of the
unaffected leg.
Prescribed footwear is needed once the ulcer is healed,
again following the recommendations for people at high-
risk of ulceration. When prescribed footwear cannot be
made available immediately when the ulcer has healed,
continuation in the offloading device meeting the off-
loading requirements is needed until the prescribed
footwear becomes available (see further details under
considerations on footwear provision).
Discussion
This new 2017 Diabetic Foot Australia footwear guide-
line has updated the 2013 Australian footwear guideline
to reflect the best available evidence from contemporary
studies investigating footwear interventions, inter-
national guidelines and expert opinion. We have formu-
lated 10 key recommendations to guide health
professionals in selecting the most appropriate footwear
to meet the specific foot risk needs of an individual with
diabetes (Table 2), and provided the rationale behind
these recommendations. In this discussion, we will add
considerations on footwear provision, education and ad-
herence, cultural and geographical differences, and
methodology and terminology related to this guideline.
These consideration provide further background with
the recommendations, and discuss aspects relevant for
implementation of the recommendations in daily clinical
practice.
Considerations on footwear provision
When providing footwear to a person with diabetes, en-
sure they know their foot risk status and confirm this via
an evidence-based screening by an appropriately trained
healthcare professional [31]. In addition to the foot
screening, other factors that should be considered in-
clude the persons gait pattern, activity levels, occupa-
tion, level of mobility, living situation, cultural beliefs,
personal goals, and preferences. These factors may influ-
ence the possible options for appropriate footwear.
When providing footwear, measure the length, width,
depth and girth of the foot the footwear needs to accom-
modate and ensure that the footwear follows the criteria
in Tables 3 and 4. For length and width, we suggest at a
minimum using a Brannock measuring device [44].
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 9 of 14
Although new scanning devices are becoming available to
measure foot shape, we still suggest depth requires clinical
assessment until accuracy of these devices can be inde-
pendently quantified, taking into account that people with
peripheral neuropathy cannot feel whether depth is accur-
ate. Evaluate the shoe fit with the person in standing pos-
ition, preferably at the end of the day to ensure that any
developing oedema is taken into account. Further consid-
erations in relation to oedema are footwear height (high
footwear may have a compression function), outdoor
temperature, and changes in oedema treatment.
The timing of footwear provision is important for any
footwear that is not pre-fabricated. This becomes even
more important when a person with diabetes at inter-
mediate- or high-risk does not have appropriate foot-
wear at a given moment. The longer a person needs to
wait to receive appropriate footwear, the more steps they
will take in inappropriate footwear, potentially increasing
the repetitive stresses on the foot and in turn the risk for
foot ulceration. Timing is most important for people
with a recently healed plantar foot ulcer. Delivery of
their prescribed footwear should be coordinated to a
point as close to healing as possible. Ideally, the transi-
tion from an offloading device required to heal the ulcer
to the preventative footwear is immediate. Any delay in
this transition increases the risk of ulcer recurrence.
When appropriate preventative footwear is not available
for a person with a nearly healed foot ulcer, footwear
prescription should be initiated before the ulcer is
healed. Prescription can be initiated when foot shape
(especially volume), structure and function are not ex-
pected to change during the healing process, and should
take the manufacturing time-schedule into account.
When prescribed footwear cannot be made available im-
mediately when the ulcer has healed, continuation in the
offloading device meeting the offloading requirements is
needed until the prescribed footwear becomes available.
Further, when new footwear is provided to a person with
diabetes after healing a foot ulcer, advise them that a
wear-inperiod may be needed where they alternate the
new footwear with the offloading device that was re-
quired to heal the ulcer, and that they should be extra
vigilant with checking of their foot health in this period.
In Australia, various state-based schemes are available
that may provide financial assistance to people with dia-
betes who require medical-grade footwear. However,
these schemes change over time and discussion of the
specific schemes is outside the scope of this guideline.
Considerations on education and adherence to wearing
footwear
Early education on the importance of adequate footwear
for foot health is important for all people with diabetes.
This education needs to continue life-long, and needs to
be expanded if a persons level of risk of foot ulceration in-
creases. The importance of footwear for people with dia-
betes should be discussed in the context of the individuals
foot risk status and health literacy [45]. Education should
aim to increase peoples understanding of the requirements
of their footwear to adequately fit, protect and accommo-
date their feet. This may also include, but is not limited to,
education on proper donning of the footwear, the import-
ance of wearing socks in footwear to reduce shear and fric-
tion, and explaining the risks to foot health of inappropriate
footwear such as slippers and sandals, of narrow heels, of
heelshigherthan3cm,andofpointy,flatorhardtoe
boxes. Education should further focus on motivating
people with diabetes at intermediate- or high-risk of
foot ulceration to wear their footwear at all times.
Footwear can only be effective when it is worn, and
adherence to wearing footwear is an important factor
in foot ulcer prevention [17, 23, 26, 30].
Achieving better adherence is a challenge, and unfor-
tunately we found no intervention studies on the effect
of interventions that aim to increase footwear adherence
in people with diabetes [17, 41]. However, we found a
number of observational studies investigating reasons
for (non-)adherence to footwear [26, 28, 4549]. An im-
provement in walking has been described as the most
important footwear-related characteristic affecting ad-
herence, while the importance of cosmetic appearance
and ease of use varies greatly between people [28, 48].
Rather than focussing on footwear characteristics, it is
suggested in various studies that personal perceptions,
values and experiences are more important factors to
improve adherence [26, 28, 4549]. A perceived benefit
of footwear is associated with increased adherence to
wearing the footwear [26], and conversely, a lack of un-
derstanding of the need for footwear hinders adherence
[28]. Acceptance of the need for footwear is another im-
portant factor affecting adherence [28, 46, 47]. This does
not only concern accepting the need for footwear, but
also acceptance of the persons underlying diabetic foot
disease [28, 46, 47]. Footwear has been described as a
visible representation of the disease, and people with
diabetes at-risk of foot ulceration may choose to moder-
ate their adherence to align with functional require-
ments and societal norms [28, 46, 47].
These personal values and experiences cannot be
assessed using a standardised measurement device.
Adequate communication between healthcare profes-
sionals and patients is needed to assess these perceptions
[45, 50]. For this communication to be effective, it
should be person-centred, not footwear-centred [45, 50].
Footwear is very personal, and this should be taken into
account during education and communication to ensure
maximum acceptance of and adherence with the foot-
wear provided [28, 47, 50].
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 10 of 14
For people at intermediate- or high-risk of foot ulcer-
ation, the importance of adherence to wearing appropri-
ate footwear both indoors and outdoors needs extra
attention. People at risk of foot ulceration have been
found to perform the majority of their total daily steps
indoors [30, 42], while their adherence to wearing their
footwear is significantly lower indoors compared to out-
doors [30]. To improve adherence, people may need to
be made aware of the greater repetitive stresses on their
feet when at home resulting from the greater number of
steps. It has also been suggested to provide separate
footwear for indoor and outdoor use [30]. For people
from cultures that may prefer not to wear normalfoot-
wear indoors, it is suggested that health professionals
consider providing indoor footwear that is manufactured
to not look like normalfootwear, which may then be
more acceptable to be worn indoors.
Considerations on cultural and geographical differences
In this guideline, we describe features and criteria for
footwear for people with diabetes, and specific recom-
mendations based on a persons foot ulcer risk following
the NHMRC risk classification. Footwear is very per-
sonal and multiple other factors may need to be taken
into account when providing footwear to a person with
diabetes and ensuring this footwear is being used. We
acknowledge the cultural differences in regard to foot-
wear behaviour, specifically for Aboriginal and Torres
Strait Islander people and from other diverse ethnic
backgrounds. Furthermore, individuals in geographically
rural and remote areas of Australia may have a limited
range of footwear options available to them, and limited
access to appropriately trained professionals. However,
we decided not to provide specific recommendations for
different cultures or for people living in rural and re-
mote areas. The criteria and recommendations in this
guideline are to be seen as the standards to be achieved,
and these recommendations can be used by clinicians in
their communications to discuss the footwear require-
ments for each persons situation. Specific circumstances
may require that a compromise is made to the recom-
mendations, which then may be considered to be better
than no footwear at all. However, in our opinion, offer-
ing deviations from the standards in this guideline, with-
out supporting evidence and solely based on specific
cultural or geographical backgrounds of people, does not
align with offering equality of best practice care for all
people and may increase the risk of foot ulceration and
will weaken this guideline. Rather, we encourage health-
care professionals to use this guideline to discuss foot-
wear requirements with people with diabetes, to try and
achieve, if needed, a compromise that is optimal for the
persons situation that most closely aligns with the
requirements and recommendations described in this
guideline.
Considerations on methodology and terminology
We have based this update of the 2013 guideline on con-
temporary evidence-based guidelines [10, 14, 15, 31], sci-
entific evidence from systematic reviews [1722],
randomised controlled trials [23, 24], observational stud-
ies [9, 2530, 3234], and expert opinion, involving ex-
perts from eight different disciplines involved in the
treatment of people with diabetic foot disease. However,
this should not be looked upon as an evidence-based
guideline, as we did not follow a specific guideline devel-
opment methodology. Developing evidence-based guide-
lines is an extensive and costly process. With recent
studies providing a much stronger evidence-base for foot-
wear requirements for people with diabetes we felt that a
new footwear guideline to update information in the
NHMRC guideline [31] and the 2013 Australian practical
guideline on footwear provision [16] was more important
than waiting for completion of a full evidence-based
guideline. Compared to the recommendations from the
2013 guidelines, some have not changed, and a number of
new ones have been added. These include the need for
health professionals to prescribe medical grade footwear
that has demonstrated plantar pressure reducing effects at
high-risk plantar areas for those people with a healed
plantar foot ulcer, to review the adequacy of any pre-
scribed footwear every three months, and to treat a
plantar foot ulcer primarily with appropriate offload-
ing devices. With this current document, healthcare
professionals can immediately start to implement the
new footwear evidence to begin to further reduce the
large national burden of diabetic foot disease.
The specific footwear requirements are closely re-
lated to an individuals foot risk status. This means
that to provide people with diabetes with appropriate
footwear, their foot risk status must be assessed first.
We followed the classification as provided in the
NHMRC guideline [31]. Other countries may use dif-
ferent risk classifications, and we advise healthcare
professionals to ensure they use the guideline that is
applicable in their own country with regard to foot
risk status assessment. In this guideline, we did not
separate between intermediate- and high-risk. The
first reason for doing so was that some recommenda-
tions do not depend on foot risk status per se, but on
thepresence(orabsence)ofthespecificriskfactorsof
foot deformity or previously healed ulcer. To cover
these differences, specific recommendations were
needed that applied both to people at intermediate-
and high-risk. Further, combining both groups while in-
cluding specifically targeted recommendations also
gives healthcare professionals from other countries the
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 11 of 14
opportunity to match the recommendations in this
guideline with their own countrysfootriskstatusclas-
sification system. Finally, the recommendations that did
not target a specific risk factor were similar for people
at intermediate- or high-risk, which means they could
be combined.
As recommended in this guideline, people at inter-
mediate- or high-risk of foot ulceration should be
instructed to obtain their footwear from an appropriately
trained professional with demonstrated competencies in
footwear fitting for people with diabetes. We have not
defined appropriately trainedor demonstrated compe-
tencies, as that was beyond the scope of the current
document. However, as a minimum, we suggest an ap-
propriately trained professional should be able to show
documented evidence of their training and competency,
and should meet the standards of their profession when
such standards are available. This way, other healthcare
professionals may confidently inform people with dia-
betes where to obtain their footwear.
The methodology followed to write this guideline does
have some limitations. The first, not following a guide-
line development methodology, has been discussed
above. A second is that no patient advocates were in-
volved in its creation. This is a consequence of not fol-
lowing a specific guideline methodology, and we hope
that this will be done in the next update of the NHMRC
guideline [31]. A third is the limited evidence base with
regard to the recommendations for people at low-risk of
ulceration [17, 41]. These recommendations might be
seen as good practice statements, a terminology used
in official guideline development for recommendations
that are predominantly based on expert opinion and
standard of practice, when limited evidence is available
[51]. As argued in other publications, it is hoped that
researchers and healthcare providers combine efforts
to build a stronger research evidence base for these
recommendations [41]. Finally, we are unaware of
cost-effectiveness information for any of the proposed
footwear interventions [17], and thus no such specific
information can be added to this guideline. However, a re-
cent Australian cost-effectiveness analysis reported appro-
priately prescribed footwear as part of a suite of optimal
diabetic foot care practice was always cheaper than stand-
ard care, and with the high costs associated with foot ul-
ceration [1, 52, 53], it is likely that preventative footwear
efforts in this regard will be cost-saving [41].
Conclusion
Appropriate footwear is important for all people with dia-
betes, to prevent foot ulceration and reduce the burden of
diabetic foot disease. This guideline contains 10 key rec-
ommendations to guide health professionals managing
people with diabetes choosing the most appropriate
footwear for the persons specific foot risk needs. We hope
that this guideline will be used to ensure that all Austra-
lians with diabetes have access to, and are provided with,
appropriate footwear to meet their needs. This should im-
prove footwear practice in Australia, and reduce the bur-
den of diabetic foot disease for people and the nation.
Abbreviations
IWGDF: International Working Group on the Diabetic Foot; NHMRC: National
Health and Medical Research Council
Acknowledgements
The authors would like to acknowledge the support of the Australian
Governments Cooperative Research Centres Program.
Funding
Writing of this guideline by the first author was supported via the Australian
Governments Cooperative Research Centres Program.
Availability of data and materials
Not applicable
Authorscontributions
JvN wrote the first version of the manuscript. PAL and PW provided critical
review and expert opinion on this first version. A second draft incorporating
consensus feedback from the three authors was sent to all authors, who
provided critical review and their expert opinion. A third draft was written by
JvN incorporating all feedback, and again sent to all authors. This process
was repeated one more time, to reach consensus of all authors, leading to
the final version of the guideline, approved by all authors.
Ethics approval and consent to participate
Not applicable
Consent for publication
Not applicable
Competing interests
JJvN, PAL, DGA, SAB, RF, KH, EK, MM, BP, KP, JP, PRW: nothing to declare in
relation to this manuscript.
KHS runs a Pedorthic Clinic in Dee Why, NSW, Australia.
HBM is Editor-in-Chief of Journal of Foot and Ankle Research. It is journal pol-
icy that editors are removed from the peer review and editorial decision
making processes for papers they have co-authored.
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1
School of Clinical Sciences, Queensland University of Technology, Brisbane,
QLD, Australia.
2
Diabetic Foot Australia, Brisbane, QLD, Australia.
3
Wound
Management Innovation Cooperative Research Centre, Brisbane, QLD,
Australia.
4
Allied Health Research Collaborative, Metro North Hospital &
Health Service, Brisbane, QLD, Australia.
5
Southern Arizona Limb Salvage
Alliance (SALSA), Department of Surgery, University of Arizona College of
Medicine, Tucson, AZ, USA.
6
Department of Rehabilitation, Academic Medical
Center, University of Amsterdam, Amsterdam Movement Sciences,
Amsterdam, the Netherlands.
7
Vascular Surgery, The University of Adelaide,
Adelaide, South Australia, Australia.
8
University Dean of Clinical Innovation,
Professor of Wound Healing Research, Cardiff University, Cardiff, UK.
9
High
Risk Foot Service, Liverpool Hospital, South Western Sydney Local Health
District, Sydney, NSW, Australia.
10
Discipline of Podiatry, School of Allied
Health, College of Science, Health and Engineering, La Trobe University,
Bundoora, VIC, Australia.
11
La Trobe Rural Health School, College of Science,
Health and Engineering, La Trobe University, Bendigo, VIC, Australia.
12
Department of Rehabilitation Medicine University of Groningen, University
Medical Center Groningen, Department of Rehabilitation Medicine,
Groningen, the Netherlands.
13
Wound Consultant, Trojan Health, Perth, WA,
van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 12 of 14
Australia.
14
School of Health and Human Sciences (Pedorthics) Southern
Cross University Gold Coast Campus, Bilinga, QLD, Australia.
15
Diabetic Foot
Unit, Royal Melbourne Hospital, Melbourne, VIC, Australia.
Received: 4 July 2017 Accepted: 27 December 2017
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5(1):24. -1146-5-24
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van Netten et al. Journal of Foot and Ankle Research (2018) 11:2 Page 14 of 14
... En cuanto a la incidencia, cuatro estudios coincidían con que la mayor parte de los enfermos que sufren ND eran diabéticos tipo 25,10,18,19 . Esto podría deberse a la mayor prevalencia de DM 25,10 . ...
... En cuanto a la incidencia, cuatro estudios coincidían con que la mayor parte de los enfermos que sufren ND eran diabéticos tipo 25,10,18,19 . Esto podría deberse a la mayor prevalencia de DM 25,10 . ...
... Del conjunto de estudios incluidos en esta revisión, 5 se enfocaron en las complicaciones del pie diabético. Todos ellos coinciden, en que la estrategia más importante es la prevención por su gran efectividad 12,13,[25][26][27] . ...
Article
Full-text available
Introducción: La nefropatía diabética es una de las complicaciones más importantes de la diabetes. Su desarrollo va desde estadios iniciales, hasta insuficiencia renal crónica terminal, requiriendo la entrada en un programa de tratamiento renal sustitutivo.Objetivos: Conocer y sintetizar la evidencia científica sobre el tratamiento renal sustitutivo con diálisis en el paciente diabético.Metodología: Se llevó a cabo una revisión integrativa siguiendo las recomendaciones de la declaración PRISMA, en las bases de datos PubMed y Scielo. La estrategia de búsqueda se estableció con los siguientes términos MeSH: ‘’Diabetes Mellitus’’, ‘’Renal Dialysis’’, ‘’Hemodialysis’’, ‘’Kidney diseases’’, ‘’Renal replacement therapy’’, ‘’Kidney treatment’’, ‘’Diabetic foot’’.Resultados: Se seleccionaron 22 artículos. De ellos, 17 fueron revisiones sistemáticas, 1 guía de práctica clínica, 1 estudio descriptivo transversal, 1 estudio observacional analítico, y 2 capítulos de libro. De la revisión emergieron las siguientes variables: tipo de diabetes, edad, evolución, tipo de tratamiento renal sustitutivo, pie diabético y prevención.Conclusiones: Se observa una gran heterogeneidad en la evolución de la nefropatía diabética. Por lo tanto, determinar el tratamiento renal sustitutivo para el paciente diabético se convierte en un desafío. El manejo del pie diabético, como principal complicación de estos pacientes, se centra en la prevención, apoyada por una buena educación. La prevalencia de la nefropatía diabética va en aumento, por lo que una mejora en la estrategia de prevención de la enfermedad podría cambiar el curso de la misma.
... While the provision of MGF in patients with a history of DFU has historically necessitated a trial-anderror approach [5], in-shoe pressure analysis provides the ability to analyse plantar pressures and modify footwear to optimise offloading, with reported mean peak pressure (MPP) reduction ranging from 23%-30.2% [5,6]. Current national and international guidelines provide a strong recommendation for patients with a history of DFU to be fitted with MGF that demonstrates plantar pressure reducing capacity to reduce the risk of foot ulcer recurrence [3,4,7]. International guidelines define plantar pressure reduction as ≥ 30% reduction in peak pressure compared to the current footwear, or MPP < 200 kPa at the site of previous ulceration (when measured with a validated and calibrated system with sensor size of 2cm 2 ) [3]. ...
... Participants were eligible if they owned MGF and custom orthoses or pre-fabricated accommodative orthoses issued within the last 12 months. MGF was defined according to the criteria described in the recent guidelines by Van Netten et al. [7] and included fully customised or pre-fabricated footwear with features that reduce the risk of DFU, such as extra depth or width, or a modified sole (e.g. rigid forefoot rocker). ...
Article
Full-text available
Background Medical grade footwear (MGF) with demonstrated plantar-pressure reducing effect is recommended to reduce the risk of diabetes-related foot ulceration (DFU). Efficacy of MGF relies on high adherence (≥ 80%). In-shoe pressure analysis (IPA) is used to assess and modify MGF, however, there is limited evidence for the impact on patient adherence and understanding of MGF. The primary aim of this study was to determine if self-reported adherence to MGF usage in patients with previous DFU improved following IPA compared to adherence measured prior. The secondary aim was to determine if patient understanding of MGF improved following in-shoe pressure analysis. Methods Patients with previous DFU fitted with MGF in the last 12 months were recruited. The first three participants were included in a pilot study to test procedures and questionnaires. MGF was assessed and modified at Week 0 based on findings from IPA using the Pedar system (Novel). Patients completed two questionnaires, one assessing patient adherence to MGF at Week 0 and Week 4, the other assessing patient understanding of MGF before and after IPA at week 0. Patient understanding was measured using a 5-point Likert scale (strongly disagree 1 to strongly agree 5). Patient experience was assessed via a telephone questionnaire administered between Weeks 0–1. Results Fifteen participants were recruited, and all completed the study. Adherence of ≥ 80% to MGF usage inside the home was 13.3% ( n = 2) pre-IPA and 20.0% ( n = 3) at Week 4. Outside the home, ≥ 80% adherence to MGF was 53.3% ( n = 8) pre-IPA, and 80.0% ( n = 12) at Week 4. Change in scores for understanding of MGF were small, however, all participants reported that undergoing the intervention was worthwhile and beneficial. Conclusions Self-reported adherence inside the home demonstrated minimal improvement after 4 weeks, however, adherence of ≥ 80% outside the home increased by 27%, with 80% of all participants reporting high adherence at Week 4. Participants rated their learnings from the experience of IPA as beneficial.
... Reducing plantar pressures is considered a key factor for wound healing and the prevention of ulcer recurrence [32,33]. Footwear and insoles are important treatment modalities for offloading these pressures [34,35]. The desired offloading threshold should be <200 kPa to ensure ulcer-free survival at the forefoot [36]. ...
... A patient-centric study design for footwear intervention in people with diabetes is non-existent [40,71]. National and international guidelines [35,72] recommend footwear and insole features to prevent foot ulcer occurrence and recurrence in people with diabetes. They also highlight the importance of adherence to them for improved clinical outcomes, but the guideline on improved adherence is non-existent. ...
Article
Full-text available
Background Foot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy. Methods This study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants’ self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis. Discussion This is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants’ preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020
... Previous randomized clinical trials [4][5][6] have demonstrated that TF can reduce the recurrence rate of plantar ulcers by 20%-30%. Typically, TF is part of the usual nonpharmacological clinical-based intervention for patients in remission from ulcers [7]. In the Netherlands, the average annual treatment cost is approximately 60 million Euros [8]. ...
... Foot complications are commonly seen with increased plantar pressure, especially in a diabetic foot with neuropathy causing non-traumatic lower extremity amputation [4,5]. Foot complications resulting in amputation begin with elevated plantar pressure and shear stresses that are directly associated with ulceration [6]. The occurrence of diabetic foot ulcers resulting from abnormal peak plantar pressure are found under the metatarsal heads and hindfoot, with a recurrence rate of more than 80% within three years after recovery [7]. ...
Article
Full-text available
To reduce the trial and error in a real clinical scenario, the finite element analysis (FEA) can be effectively used to simulate various effective pad designs and a material selection to reduce and redistribute peak plantar pressure in a diabetic foot with neuropathy. The aim of this study was to investigate the effect of pad design and material stiffness on the reduction in plantar pressure in a diabetic foot with neuropathy using FEA. Three-dimensional foot models with a customized insole (CMI) were created to study the peak contact pressure. Ethylene vinyl acetate, Nora® Lunalastike, and thermoplastic polyurethane were assigned to the top, middle, and base layers of the CMI, respectively. Two types of pads were proposed: a heel pad and a heel–forefoot pad. Four different materials with different stiffnesses were assigned as pad materials including a void pad. The FEA revealed that pads with soft materials reduced peak plantar pressure more effectively than stiffer pads. The use of a softer heel–forefoot pad reduced the peak plantar pressure at the midfoot and forefoot compared with other pads. The findings suggest that the material and design selection for the fabrication of CMIs with pads are important factors in reducing plantar pressure and may be useful in the management of a neuropathic diabetic foot.
... Th e chronic metabolic derangements associated with diabetes mellitis produce complications which may be microvascular such as neuropathy, nephropathy and retinopathy and/or macrovascular such as coronary artery disease, stroke and peripheral artery disease as mentioned by Papatheodorou K. et al. 15 Eming et al. 6 in his study mentioned that immune mechanisms as well as wound healing processes are also compromised in chronic diabetes mellitis Muco-cutaneous manifestations are frequent in DM and include both infective and non-infective conditions as described by Duff et al. 4 Mishra et al., 14 and van Nett en et al. 18 describes in their study that in diabetis, the presence microvascular, immune and healing compromises as well as repetitive injury to feet, there is high risk of development of diabetic foot ulcers. ...
... Wearing inappropriate shoes or walking barefoot can cause frequent local mechanical pressure on the feet. Therefore, it is recommended that patients with diabetes wear appropriate shoes to avoid putting too much pressure on their feet [27]. In this study, the self-care score of diabetic foot decreased with age, which is consistent with the results of the study by Miikkola et al. (2019) [28]. ...
... To prevent diabetic foot ulcers, various offloading interventions (e.g., offloading devices, special therapeutic footwear, surgery, and other offloading interventions) are utilized in clinical practice worldwide [11][12][13][14][15][16]. Among these offloading methods, special therapeutic footwear, recommended by the International Working Group on the Diabetic Foot (IWGDF) for persons at risk for foot ulceration (IWGDF risk 2-3) [8], was demonstrated to be capable of redistributing the pathological mechanical pressure and relieving the abnormal load on the plantar foot surface (i.e., the weight-bearing surface of the foot) [8,[17][18][19] and could be routinely worn at all times, both indoors and outdoors [8]. ...
Article
Full-text available
Objective: To reduce diabetic foot ulcer (DFU) occurrence or recurrence, diabetic therapeutic footwear is widely recommended in clinical practice for at-risk patients. However, the effectiveness of therapeutic footwear is controversial. Thus, we performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to examine whether special therapeutic footwear could reduce the incidence of DFU. Method: We systematically searched multiple electronic databases (Medline, EMBASE, and EMB databases) to identify eligible studies published from inception to June 11, 2021. The database search, quality assessment, and data extraction were independently performed by two reviewers. Efficacy (i.e., incidence of DFU) was explored using the R'meta' package (version 4.15-1). To obtain more robust results, the random-effects model and the Hartung-Knapp-Sidik-Jonkman method were selected to assess pooled data. Metaregression analysis and sensitivity analysis were performed to explore heterogeneity, and publication bias was assessed by a visual inspection of funnel plots and the AS-Thompson test. Results: Eight RCTs with a total of 1,587 participants were identified from the search strategy. Compared with conventional footwear, special therapeutic footwear significantly reduced the incidence of DFU (RR 0.49; 95% CI, 0.28-0.84), with no evidence of publication bias (P = 0.69). Unexpectedly, the effectiveness of special therapeutic footwear had a reverse correlation with the intervention time (coefficient = 0.085, P < 0.05) in the metaregression analysis. Conclusion: Special therapeutic footwear with offloading properties is effective in reducing the incidence of DFU. However, the effect may decrease gradually over time. Despite undefined reasons, the optimal utility time and renewal frequency of special therapeutic footwear should be considered.
... There is a guideline containing 10 key recommendations to guide health professionals in selecting the most appropriate footwear to meet the specific foot risk needs of an individual with diabetes. [21] In a retrospective cohort study, [22] individualized homeopathic treatment was associated with better glycaemic control when compared with standard conventional treatment alone. A prospective, observational study [23] of 156 patients with DFU with positive results has been published. ...
Article
Full-text available
Diabetes mellitus (DM) is one of the major health issues. Patients with DM are prone to multiple complications including diabetic foot ulcer (DFU). DM increases the incidence of foot ulcers by 11-fold, which counts for more than 80% of all amputations. Reductions in frequency of the development of ulcer can be achieved by taking a multidisciplinary approach to patient management. Studies reveal promising effects of homoeopathy in reducing the associated symptoms and healing the ulcer. The given case is of a diabetic patient having a deep punched out foot ulcer. He was diabetic for the last 10 years and was under conventional anti-diabetic oral medication. The ulcer was above the medial malleolus in the left leg for 7 days. It was painless with burning and itching sensation near the margin with a yellowish pustular sticky discharge. The ulcer was of size 30 mm x 30 mm, depth of 3 mm, circular in shape, well-defined margin, with slough, yellowish floor. There was no extension or involvement to bones or tendon. As per Wagner system, it is found to be of grade-I. On the basis of totality of symptoms the case was analysed. Repertorization was done using Kent's repertory with the help of HOMPATH software. Subsequently, Kali bichromicum was the remedy of choice. Four doses of 200 th centesimal potency, to be taken once daily, were prescribed. Assessment of the ulcer was done using Wagner system and photography of the lesion at the same angle with similar light exposure. By the end of one and half months, the ulcer was found to be healed up. Additionally, it was found that the blood glucose level also dropped down despite there was no modification in the ongoing conventional treatment. Observational studies and randomized controlled trials with sound methodology are recommended as next levels of evidence-based approach.
Article
Diabetic individuals with peripheral neuropathy are at risk for the development of foot ulcers due to musculoskeletal abnormalities and abnormal loading in the gait cycle leading to elevated plantar pressures. To prevent diabetic foot ulcers, practitioners should regularly screen patients for the presence of neuropathy as well as neuroarthropathies and prescribe the appropriate shoes and orthotics based on the best available clinical evidence. Although not widely available, there is potential for data-driven customization of orthotics and shoe wear based on plantar pressure data to prevent the development of diabetic foot ulcers more effectively, and ultimately prevent lower limb amputations.
Article
Full-text available
Objective: There is a paucity of research on patients presenting with uninfected diabetic foot ulcers (DFU) that go on to develop infection. We aimed to investigate the incidence and risk factors for developing infection in a large regional cohort of patients presenting with uninfected DFUs. Methods: We performed a secondary analysis of data collected from a validated prospective state-wide clinical diabetic foot database in Queensland (Australia). Patients presenting for their first visit with an uninfected DFU to a Diabetic Foot Service in one of thirteen Queensland regions between January 2012 and December 2013 were included. Socio-demographic, medical history, foot disease history, DFU characteristics and treatment variables were captured at the first visit. Patients were followed until their DFU healed, or if their DFU did not heal for 12-months, to determine if they developed a foot infection in that period. Results: Overall, 853 patients were included; mean(standard deviation) age 62.9(12.8) years, 68.0% male, 90.9% type 2 diabetes, 13.6% indigenous Australians. Foot infection developed in 342 patients for an overall incidence of 40.1%; 32.4% incidence in DFUs healed <3 months, 55.9% in DFUs healed between 3-12 months (p<0.05). Independent risk factors (Odds Ratio (95% confidence interval)) for developing infection were: DFUs healed between 3-12 months (2.3 (1.6-3.3)), deep DFUs (2.2 (1.2-3.9)), peripheral neuropathy (1.8 (1.1-2.9)), previous DFU history (1.7 (1.2-2.4)), foot deformity (1.4 (1.0-2.0)), female gender (1.5 (1.1-2.1)) and years of age (0.98 (0.97-0.99)) (all p<0.05). Conclusions: A considerable proportion of patients presenting with an uninfected DFU will develop an infection prior to healing. To prevent infection clinicians treating patients with uninfected DFUs should be particularly vigilant with those presenting with deep DFUs, previous DFU history, peripheral neuropathy, foot deformity, younger age, female gender and DFUs that have not healed by 3 months after presentation.
Article
Full-text available
Diabetic foot ulcer is a serious complication in patients with diabetes. In most outcome studies of this condition, there is a combination of various types of ulcer and ulcer locations. Plantar ulcers are usually localized to the forefoot, and constitute a quarter of all diabetic foot ulcers. There are a limited number of studies regarding development of new ulcers following healing of a plantar forefoot ulcer, and there are no uniform definitions of recurrent and other new ulcers. The aim of this study was to evaluate the outcome of a large cohort of consecutively treated patients with diabetes mellitus and a healed planter forefoot ulcer (n=617) with regard to development, characteristics, and outcome of recurrent and other new ulcers. Patients were followed consecutively and prospectively with a two-year follow-up, according to a pre-set protocol. Out of 617 patients, 250 (41%) did not develop any new ulcer, 262 (42%) developed a new ulcer, 87 (14%) died and 18 (3%) were lost at two years following healing of a plantar forefoot ulcer. Thirty-four per cent developed other new ulcers (112 on the same foot and 99 on the contralateral foot), whereas 51 patients (8%) developed a recurrent ulcer (at the same site and foot). Of the patients who died within two years, 30 patients had developed other new ulcers. The risk of a recurrent ulcer in patients with diabetes and a healed plantar forefoot ulcer was only eight per cent within two years, whereas other new ulcers, on the same foot or on the contralateral foot, was seen in 4 out of 10 patients indicating the need for further preventive measures and surveillance in these patients. We suggest a concise definition for new ulcer to be used in future research. This article is protected by copyright. All rights reserved.
Article
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Background and aim: Clients' acceptance and adherence with orthoses can be influenced by a clinician's communication skills. In this clinical note, we describe two communication techniques, in the context of therapeutic footwear. Technique: Person-centred communication involves engaging with and listening to the attitudes of the client towards their condition, as well as discussing acceptance and expectations, in a structured consultation. Building a relationship is crucial and requires clients to feel heard and understood. An important influence on the acceptance and adherence is that a client makes a conscious decision to receive their device. This active receipt can be facilitated through shared decision making, wherein clinicians give clear, relevant and meaningful examples, based on clinical evidence, and ensure this is understood. Discussion: Two communication techniques for clinicians providing therapeutic footwear are described. These can be adapted for use with provision of other assistive technologies to improve client acceptance and adherence. Clinical relevance: Small changes in how clinicians communicate to their clients in daily practice can have a big influence on the subsequent acceptance and adherence with therapeutic footwear and indeed other prescribed assistive technologies.
Article
Full-text available
Objective: Physical activity variability is a risk factor for diabetic foot ulcers (DFU). Geographic context may influence variability. This study developed initial methods for monitoring location-specific physical activity in this population. Secondarily, preliminary comparisons in location-specific physical activity were made between patients at risk versus patients with active DFU. Methods: Five at-risk and 5 actively ulcerated patients were monitored continuously for 72 hours with physical activity and GPS monitors. A custom algorithm time synchronized the 2 devices' data. Results: On average for all 10 subjects, 1.5 ± 2.1% of activity lacked a corresponding GPS location. 80 ± 11% of self-reported activity events per subject had a GPS identified location. The GPS identified locations were in agreement with the self-reported locations 98 ± 6% of the time. DFU participants' weight-bearing activity was 188% higher at home than away from home. At-risk participants showed similar weight-bearing activity at home as active DFU participants, however, at-risk participants had 132% more weight-bearing activity away-from-home. Conclusions: Objectively monitoring location-specific physical activity proved feasible. Future studies using such methodology may enhance understanding of pathomechanics and treatment of DFU.
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In-shoe pressure measurement devices are used in research and clinic to quantify plantar foot pressures. Various devices are available, differing in size, sensor number and type; therefore accuracy and repeatability. Three devices (Medilogic, Tekscan and Pedar) were examined in a 2 day × 3 trial design, quantifying insole response to regional and whole insole loading. The whole insole protocol applied an even pressure (50–600 kPa) to the insole surface for 0–30 s in the Novel TruBlue™ device. The regional protocol utilised cylinders with contact surfaces of 3.14 and 15.9 cm2 to apply pressures of 50 and 200 kPa. The validity (% difference and Root Mean Square Error: RMSE) and repeatability (Intra-Class Correlation Coefficient: ICC) of the applied pressures (whole insole) and contact area (regional) were outcome variables. Validity of the Pedar system was highest (RMSE 2.6 kPa; difference 3.9%), with the Medilogic (RMSE 27.0 kPa; difference 13.4%) and Tekscan (RMSE 27.0 kPa; difference 5.9%) systems displaying reduced validity. The average and peak pressures demonstrated high between-day repeatability for all three systems and each insole size (ICC ≥ 0.859). The regional contact area % difference ranged from −97 to +249%, but the ICC demonstrated medium to high between-day repeatability (ICC ≥ 0.797). Due to the varying responses of the systems, the choice of an appropriate pressure measurement device must be based on the loading characteristics and the outcome variables sought. Medilogic and Tekscan were most effective between 200 and 300 kPa; Pedar performed well across all pressures. Contact area was less precise, but relatively repeatable for all systems.
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