Systemic Review With Specific Article

SUPPLEMENT ARTICLE

Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update)

Sicco A. Bus1 | David G. Armstrong2 | Catherine Gooday3,4 | Gustav Jarl 5,6 | Carlo F. Caravaggi7,8 | Vijjjjay Viswanathan9 | Peter A. Lazzarini10,11 on beha;lf of the International Working Grroup on the Diabetic Foot (IWGDF)

1Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam, The Netherlands

2Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine of University of Southern California (USC), Los Angeles, California

3Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals, Norwich, UK

4School of Health Sciences, University of East Anglia, Norwich, UK

5Department of Prosthetics and Orthotics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

6University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

7Diabetic Foot Department, IRCCS Multimedica Group, Milan, Italy

8University Vita-Salute San Raffaele, Milan, Italy

9MV Hospital for Diabetes, Chennai, India

10School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia

11Allied Health Research Collaborative, The Prince Charles Hospital, Brisbane, Queensland, Australia

Correspondence

S.A. Bus, Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam, The Netherlands.

Email: s.a.bus@amsterdamumc.nl

International Working Group on the Diabetic Foot (IWGDF); www.iwgdfguidelines.org

Diabetes Metab Res Rev. 2020;36(S1):e3274. wileyonlinelibrary.com/journal/dmrr © 2020 John Wiley & Sons Ltd https://doi.org/10.1002/dmrr.3274

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Abstract

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot dis- ease since 1999. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people with diabetes and updates the previous IWGDF guideline.

We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the ben- efits and harms, patient preferences, feasibility and applicability, and costs related to the intervention.

For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a nonremovable knee-high offloading device is the first choice of offloading treatment. A removable knee-high and removable ankle-high offloading device are to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to nonremovable offloading exist. Appropriately, fitting footwear combined with felted foam can be considered as the fourth-choice offloading treatment. If non-surgical offloading fails, we recom- mend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treat- ment for healing ulcers that are complicated with infection or ischaemia and for healing plantar heel ulcers.

Offloading is arguably the most important of multiple interventions needed to heal a neu- ropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalization, and amputation.

KEYWORDS

cast, diabetic foot, foot ulcer, footwear, guidelines, offloading, surgery

 

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LIST OF RECOMMENDATIONS

1. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, use a nonremovable knee-high offloading device with an appropriate foot-device interface as the first choice of offloading treatment to promote healing of the ulcer (GRADE strength of recommendation: Strong; Quality of evidence: High). (b) When using a nonremovable knee-high offloading device to heal a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use either a total contact cast or nonremovable knee-high walker, with the choice dependent on the resources available, technician skills, patient preferences, and extent of foot deformity present (Strong; Moderate).

2. In a person with diabetes and a neuropathic plantar forefoot or mid- foot ulcer for whom a nonremovable knee-high offloading device is contraindicated or not tolerated, consider using a removable knee- high offloading device with an appropriate foot-device interface as the second choice of offloading treatment to promote healing of the ulcer. Additionally, encourage the patient to wear the device at all times (Weak; Low).

3. In a person with diabetes and a neuropathic plantar forefoot or mid- foot ulcer for whom a knee-high offloading device is contraindicated or not tolerated, use a removable ankle-high offloading device as the third choice of offloading treatment to promote healing of the ulcer. Additionally, encourage the patient to wear the device at all times (Strong; Low).

4. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, do not use, and instruct the patient not to use, con- ventional or standard therapeutic footwear as offloading treatment to promote healing of the ulcer, unless none of the abovementioned offloading devices is available (Strong; Moderate).

(b) In that case, consider using felted foam in combination with appropriately fitting conventional or standard therapeutic footwear as the fourth choice of offloading treatment to promote healing of the ulcer (Weak; Low).

5. In a person with diabetes and a neuropathic plantar metatarsal head ulcer, consider using Achilles tendon lengthening, metatarsal head resection(s), or joint arthroplasty to promote healing of the ulcer, if non-surgical offloading treatment fails (Weak; Low).

6. In a person with diabetes and a neuropathic plantar or apex digital ulcer, consider using digital flexor tenotomy to promote healing of the ulcer, if non-surgical offloading treatment fails (Weak; Low).

7. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer with either mild infection or mild ischaemia, consider using a nonremovable knee-high offloading device to promote healing of the ulcer (Weak; Low).

(b) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer with both mild infection and mild ischaemia or with either moderate infection or moderate ischaemia, consider using a removable knee-high offloading device to promote healing of the ulcer (Weak; Low).

(c) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer with both moderate infection and moderate ischae- mia or with either severe infection or severe ischaemia, primarily

address the infection and/or ischaemia, and consider using a removable offloading intervention based on the patient’s function- ing, ambulatory status, and activity level, to promote healing of the ulcer (Weak; Low).

8. In a person with diabetes and a neuropathic plantar heel ulcer, consider using a knee-high offloading device or other offloading intervention that effectively reduces plantar pressure on the heel and is tolerated by the patient, to promote healing of the ulcer (Weak; Low).

9. In a person with diabetes and a nonplantar foot ulcer, use a remov- able ankle-high offloading device, footwear modifications, toe spacers, or orthoses, depending on the type and location of the foot ulcer, to promote healing of the ulcer (Strong; Low).

1 | INTRODUCTION

Diabetes-related foot ulceration (DFU) results in a large global mor- bidity, mortality, and cost burden.1-5 DFU annually affects around 26 million people worldwide.2,4 Without appropriate care, these foot ulcers can lead to hospitalization, amputation, and death.1-5 Thus, healing of DFU is of paramount global importance.1-5

Peripheral neuropathy affects around half of all people with diabetes and leads to loss of protective sensation in the feet.2-4 Elevated levels of mechanical stress in the presence of loss of pro- tective sensation are one of the most common causes of DFU.2,6-8 Mechanical stress is composed of plantar pressures and shear accu- mulated during repetitive cycles of weight-bearing activity.2,6-8 Peripheral neuropathy can also lead to further changes in gait, foot deformity, and soft tissue, all of which can further elevate mechanical stress.7-9 Thus, the combination of loss of protective sensation and elevated mechanical stress leads to tissue damage and DFU.2,6,10 Once a DFU forms, healing is chronically delayed if the area is not effectively offloaded.2,6,10

Multiple interventions are typically required to effectively heal a DFU, including local wound management, infection management, revascularization, and pressure offloading.11,12 The first three of those interventions are covered in other parts of the International Working Group of the Diabetic Foot (IWGDF) Guidelines.12-15 In people with neuropathic DFUs, pressure offloading is arguably the most important of these interventions.10-12 There is a long standing clinical tradition of using different offloading devices, footwear, surgery, and other offloading interventions to heal DFUs.6,10,16-18 Previous IWGDF Guidelines have shown that sufficient evidence is available to support the use of nonremovable knee-high offloading devices to heal plantar forefoot ulcers, over all other offloading interventions.10,12,19 It also identified that more high-quality stud- ies are needed to confirm the promising effects of other offloading interventions to heal DFUs, in order to better inform practitioners about effective treatments.10,19 Over the last few years, several well-designed controlled studies have been performed in this field that add to the evidence base for offloading foot ulcers in patients with diabetes.20-23

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This guideline aims to update the previous IWGDF guideline on footwear and offloading.19 However, unlike the previous guideline, this guideline no longer includes footwear and offloading for the pre- vention of foot ulcers; it focuses only on offloading for the manage- ment of foot ulcers. Footwear and offloading for the prevention of foot ulcers are now covered by the IWGDF guideline on prevention.24 Other IWGDF guidelines in this series include those on peripheral artery disease, infection, wound healing, and ulcer classification.25-28

2 | METHODS

In this guideline, we have followed the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology, which is structured around clinical questions in the PICO format (Patient-Intervention-Comparison-Outcome), systematic searches and assessment of the available evidence, followed by developing recom- mendations and their rationale.29,30

First, a multidisciplinary working group of independent experts (the authors of this guideline) was installed by the IWGDF Editorial Board. The members of the working group devised the clinical ques- tions, which were revised after consultation with external experts from various geographical regions and the IWGDF Editorial Board. The aim was to ensure the relevance of the questions for clinicians and other health care professionals in providing useful information on offloading interventions to heal foot ulcers in people with diabetes. We also formulated what we considered critically important outcomes relevant for daily care, using the set of outcomes defined by Jeffcoate et al11 as a reference guide.

Second, we systematically reviewed the literature to address the agreed upon clinical questions. For each assessable outcome, we graded the quality of evidence based on the risk of bias of included studies, effect sizes, presence of inconsistency, and evidence of publi- cation bias (the latter where appropriate). We then rated the quality of evidence as “high,” “moderate,” or “low.” The systematic review supporting this guideline is published separately.31

Third, we formulated recommendations to address each clinical question. We aimed to be clear, specific, and unambiguous on what we recommend, for which persons, and under what circumstances. Using the GRADE system, we provided the rationale for how we arrived at each recommendation, based on the evidence from our sys- tematic review,31 expert opinion where evidence was not available, and a careful weighing of the benefits and harms, patient preferences, and financial costs (resource utilization) related to the intervention or diagnostic method.29,30 Based on these factors, we graded the strength of each recommendation as “strong” or “weak” and for or against a particular intervention or diagnostic method. All our recom- mendations (with their rationales) were reviewed by the same interna- tional experts who reviewed the clinical questions, as well as by the members of the IWGDF Editorial Board.

We refer those seeking a more detailed description on the methods for developing and writing these guidelines to the “IWGDF Guidelines development and methodology” document.32

3 | RECOMMENDATIONS

A diagrammatic overview of the recommended offloading treatment approach to heal a foot ulcer in a person with diabetes can be found in Figure 1.

In this guideline, many different offloading interventions are men- tioned. They are discussed according to the following categories: offloading devices, footwear, other offloading techniques, and surgical offloading techniques. We refer to the glossary for a definition and description of each of these offloading interventions and categories. Furthermore, many of the offloading devices and interventions rec- ommended require specific training, skills, and experience to apply properly. As these specific skills and training are not described in the studies performed and may differ between countries, we suggest that the person applying the offloading should be a properly trained health care professional who according to their national or regional standards has the knowledge, expertise, and skills necessary to manage patients with a DFU.

3.1 | What’s new?

We have made several changes to the recommendations included in this updated 2019 IWGDF offloading guideline when compared with the previous IWGDF offloading guideline.19 The main changes are the following:

• Removed any recommendations on the prevention of foot ulcers (these are now covered in the updated 2019 IWGDF prevention guideline24).

• Outlined clearly the first, second, third, and fourth choice of offloading treatment to heal a neuropathic plantar forefoot or mid- foot ulcer.

• Added one new recommendation on considerations for choosing between either a total contact cast or nonremovable knee-high walker.

• Added three new recommendations on offloading treatments for people with neuropathic plantar forefoot ulcers that are compli- cated by infection or ischaemia.

• Added a new recommendation on offloading treatments for people with neuropathic plantar heel ulcers.

3.2 | Offloading devices

PICO 1: In people with a plantar DFU, are nonremovable offloading devices compared with removable offloading devices effective to heal the DFU?

Recommendation 1a

In a person with diabetes and a neuropathic plantar forefoot or mid- foot ulcer, use a nonremovable knee-high offloading device with an

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F I G U R E 1 Flow diagram on the recommended offloading treatment for a person with diabetes and a foot ulcer

appropriate foot-device interface as the first choice of offloading treatment to promote healing of the ulcer (GRADE strength of recom- mendation: Strong; Quality of evidence: High).

Rationale

Nonremovable knee-high offloading devices consist of total contact casts (TCCs) and nonremovable walkers.19 TCCs are custom-made, knee-high, nonremovable casts, and nonremovable walkers are pref- abricated, knee-high, removable walkers rendered irremovable by applying a layer of cast or tie wrap around the device. These walkers may involve a modular insole system or have an (custom) insole added. In any case, an appropriate foot-device interface is required, meaning that peak pressures are adequately distributed and reduced at the ulcer location. Nonremovable offloading devices offer several benefits for healing a DFU over other offloading interventions, includ- ing better redistribution of pressure over the foot and lower leg and enforced adherence.6,10,19,33 These factors play an important role in the healing of foot ulcers with nonremovable offloading.

Our updated systematic review31 identified five high-quality meta-analyses of controlled trials on this topic,33-37 with much overlap present between the meta-analyses on the trials included. All found that nonremovable offloading devices result in significantly improved healing outcomes for neuropathic plantar forefoot ulcers when com- pared with removable devices (removable offloading devices or foot- wear).33-37 For those meta-analyses reporting relative risks, they found nonremovable offloading devices were 17% to 43% more likely than removable devices to heal a neuropathic plantar forefoot ulcer (P < 0.05).34,36,37 For those reporting time-to-healing, they found

nonremovable offloading devices healed ulcers 8 to 12 days quicker than removable devices (P < 0.05).33,35 We conclude that nonremovable knee-high offloading devices have clear healing benefits over removable devices. The quality of evidence is rated as high.

Possible adverse effects of nonremovable offloading devices include muscle weakness, falls, new ulcers because of poor fitting, and knee or hip complaints because of the acquired limb-length discrep- ancy when wearing the device.38-40 One may consider a shoe raise for the contralateral limb to minimize this acquired limb-length discrep- ancy. In most randomized controlled trials (RCT), the wide variation in type of adverse events, relatively small sample sizes, and low inci- dence of reported events prevented statistical testing between nonremovable and removable devices.22,23,38,41-43 However, two meta-analyses reported no differences in skin maceration or treat- ment discontinuation (combination of adverse events, voluntary with- drawal, or losses to follow-up).34,36 Additionally, six RCTs described low overall incidences (0%-20%) of adverse events, with no differ- ences evident between nonremovable and removable devices for these events, including falls, maceration, abrasions, new ulcers, infec- tions, and hospitalizations.22,23,38,41-43 Nevertheless, clinicians and other health care providers should still be aware of these adverse events. We conclude nonremovable and removable offloading devices have similar low incidences of harm.

Many patients are thought to not prefer nonremovable knee-high offloading devices as they limit daily life activities, such as walking, sleeping, bathing, or driving a car.34 Two RCTs reported on patient preferences with one reporting lower patient satisfaction with nonremovable compared with removable offloading devices23 and the

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other reporting no differences in patient satisfaction or comfort.43 One large health technology assessment reported on qualitative inter- views with 16 patients with DFU who were familiar with a variety of offloading devices.34 They found that patients rated nonremovable offloading devices as preferable after they understood the healing ben- efits of nonremovable devices, even though they rated removable offloading devices as more comfortable, allowing greater freedom and mobility.34 Practitioners may not prefer some nonremovable offloading, as surveys and epidemiological studies show low use of TCCs in clinical practice, but similar (and moderate) use of nonremovable and remov- able walkers.16-18,44 We conclude that nonremovable and removable offloading devices may be equally preferred by both patients and clinicians.

Two RCTs reported on costs with one finding one-off device/ material costs were higher for nonremovable and removable walkers than for TCCs,38 and the other finding that TCCs and nonremovable walkers were less expensive over the course of treatment than remov- able walkers.23 One large health technology assessment study system- atically reviewed the literature and found no papers on economic evaluations of nonremovable offloading devices.34 The authors then performed their own cost-effectiveness analysis, using existing litera- ture and expert opinion, which showed that the cost per patient for 3 months of treatment (including all device/materials, dressings, consul- tations, labour, complication costs, etc.) was lowest for nonremovable walkers ($876) and TCCs ($1137), compared with removable walkers ($1629) and therapeutic footwear ($1934).34 They concluded that nonremovable walkers and TCCs were superior to the other offloading interventions because they were both less expensive and more effective than removable walkers and therapeutic footwear. They also performed a cost-utility analysis that also showed that the cost per patient for 6 months of treatment (including all treatment costs and heath gains from ulcers healed and quality of life) was again low- est for nonremovable walkers ($2431) and TCCs ($2924), compared with removable walkers ($4005) and therapeutic footwear ($4940).34 We conclude nonremovable offloading devices to be more cost- effective than removable offloading devices.

Contraindications for the use of nonremovable knee-high offloading devices, based predominantly on expert opinion, include presence of both mild infection and mild ischaemia, moderate-to-severe infection, moderate-to-severe ischaemia, or heavily exudating ulcers.34-36,39,45 We refer to the IWGDF infection and PAD guidelines and the IWGDF defini- tions and criteria document for definitions on infection and ischae- mia.27,28,46 We identified no RCTs in this field that have included participants with these conditions, seemingly for safety reasons. How- ever, we did identify controlled and noncontrolled studies that indicate no additional adverse events in people with mild infection or mild ischae- mia.39,45,47-51 One low-quality systematic review investigating mostly noncontrolled studies of TCC use in people with ischaemia rec- ommended an ankle brachial index threshold of >0.55 for safe use of a TCC.52 The use of nonremovable knee-high offloading devices may also induce an increased risk of falls with several studies reporting abnormal gait changes and imbalance in people with DFU wearing knee-high offloading devices.53-55 However, in the aforementioned RCTs, there

was no increase in reported falls-related adverse events in those wearing nonremovable knee-high offloading devices.22,23,38,41-43 Further, studies investigating ankle foot orthoses, devices that share functional similari- ties to knee-high offloading devices, have shown ankle foot orthoses may help to improve balance and reduce falls in older people with neu- ropathy.56,57 Future studies should specifically investigate the effect of knee-high offloading devices on risk of falls, and we suggest falls risk assessment should be done on a patient-by-patient basis.

In summary, the quality of the evidence from the meta-analyses performed was high, even though the quality of evidence from individ- ual RCTs varied. All meta-analyses favoured the use of nonremovable knee-high over removable offloading to heal neuropathic plantar fore- foot ulcers without infection or ischaemia present. These benefits out- weigh the low incidence of harm, and with positive cost-effectiveness and mixed patient preference for the use of nonremovable over remov- able offloading devices, we grade this recommendation as strong. We refer to Recommendations 7a, 7b, and 7c for DFU that are infected or where ischaemia is present.

PICO 2: In people with a plantar DFU, are TCC compared with other nonremovable knee-high offloading devices effective to heal the DFU?

Recommendation 1b

When using a nonremovable knee-high offloading device to heal a neuropathic plantar forefoot or midfoot ulcer in a person with diabe- tes, use either a total contact cast or nonremovable knee-high walker, with the choice dependent on the resources available, technician skills, patient preferences, and extent of foot deformity present (Strong; Moderate).

Rationale

The TCC has been considered for decades the gold standard offloading intervention to heal a neuropathic plantar forefoot ulcer.19,58 Our previous guideline broadened the recommendation to a nonremovable offloading device19 to include both a TCC and a pref- abricated removable knee-high walker rendered nonremovable with an appropriate foot-device interface. However, the previous guideline did not provide a recommendation on which one is preferable to use.19

Our updated systematic review31 identified one high-quality meta-analysis on this topic34 that included three high-quality RCTs.23,59,60 The meta-analysis found no difference in ulcers healed using TCCs and nonremovable walkers (P = 0.82).34 Another low- quality RCT also found no significant difference between a TCC and nonremovable knee-high walker for ulcers healed (P = 0.99) or time- to-healing (P = 0.77).61 However, none of these four RCTs was based on a sample size calculation for equivalence.59 Thus, the non- significant results of the individual RCTs may reflect low statistical power to detect differences, although the meta-analysis should have had sufficient power. We conclude that TCCs and nonremovable knee-high walkers are equally effective to heal DFUs.

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As healing outcomes were similar, we analysed effects on the sur- rogate outcomes of plantar pressures and weight-bearing activity.11 One RCT found a significantly greater plantar pressure reduction from barefoot pressure baselines in a knee-high walker compared with a TCC at the ulcer site (91% vs 80%), the forefoot (92% vs 84%), and midfoot (77% vs 63%) (all, P < 0.05), but no difference in the heel (P = 0.11).62 However, several noncontrolled cross-sectional studies found no significant difference in plantar pressure reduction from standard footwear baselines in knee-high walkers compared with TCCs at the ulcer site, hallux, and forefoot.63-66 We found no con- trolled studies investigating weight-bearing activity. We consider TCCs and nonremovable knee-high walkers to have similar effects on reducing plantar pressures.

Three high-quality RCTs reported adverse events for TCCs and nonremovable knee-high walkers and found no significant differences (P > 0.05).23,59,60 Additionally, one meta-analysis found no significant difference for treatment discontinuation between these two devices (P = 0.52).34 While the low numbers of adverse events and treatment discontinuations may have resulted in low power to detect differ- ences, we consider these devices to have similarly low levels of harm. The same RCTs reported on patient preferences. One reported higher patient satisfaction with a nonremovable knee-high walker than with a TCC (P < 0.05),60 while another reported no differences (P > 0.05).23 Two of these RCTs also found that it took a significantly longer time to apply and remove a TCC than a nonremovable knee-high walker (by up to 14 min, P < 0.01).59,60 We conclude that patient and practi- tioner preference for either device is mixed.

Four RCTs reported on the costs of using a TCC or nonremovable knee-high walker. One low-quality RCT reported that the one-off device/material costs for a TCC were lower than for a nonremovable offloading device ($20 vs $35, P < 0.01).61 Three other, high-quality, RCTs reported that treatment costs were lower for nonremovable knee-high walkers than for TCCs.23,59,60 One reported that device/ material costs were lower ($158 vs $211, P = not reported),59 another that all offloading treatment costs (ie, device/materials, cast changes, dressings, and cast technician salary) were significantly lower ($162 vs $727, P < 0.001),60 and the third that average costs per day of treat- ment were significantly lower with a nonremovable walker than with a TCC (€83 vs €243, P < 0.05).23 The cost-effectiveness analysis of a health technology assessment showed that the cost per patient for 3 months treatment was lower per patient for a nonremovable walker than for a TCC ($876 vs $1137).34 When the costs and healing probabilities were modelled over 1000 patients with a DFU, they reported the TCC would heal 15 more ulcers (741 vs 726), but cost $260 420 more than the nonremovable knee-high walker ($1.137 vs $0.876 million). Thus, from a population-based perspective, they suggest that for each additional DFU healed using a TCC compared with using a nonremovable walker would cost a service $17 923, and therefore would not be more cost-effective in most services.34 The same study found in a cost-utility analysis that the cost per patient for 6 months treatment were lower for a nonremovable walker than for a TCC ($2431 vs $2924).34 We conclude that nonremovable walkers are generally more cost-effective than TCCs.

In summary, based on one high-quality meta-analysis of three high-quality RCT’s showing consistent results for healing between the TCC and nonremovable knee-high walkers, and with a need for larger trials to test for equivalence, we rate the quality of evidence as mod- erate. Additionally, considering the equivalence in plantar pressure benefits and adverse events, and slight preference and lower costs for a nonremovable knee-high walker, we grade this recommendation as strong. However, we recommend to base the choice for either a TCC or a nonremovable knee-high walker on availability of the device/ materials (ie, resources), skills of available cast technicians, appropri- ateness of the device to fit the level of any foot deformity (ie, a TCC with a severely deformed foot), and patient preferences.

PICO 3: In people with a plantar DFU, are removable knee-high offloading devices compared with other removable offloading devices effective to heal the DFU?

Recommendation 2

In a person with diabetes and a neuropathic plantar forefoot or mid- foot ulcer for whom a nonremovable knee-high offloading device is contraindicated or not tolerated, consider using a removable knee- high offloading device with an appropriate foot-device interface as the second choice of offloading treatment to promote healing of the ulcer. Additionally, encourage the patient to wear the device at all times (Weak; Low).

Rationale

There are circumstances when a nonremovable knee-high offloading device is contraindicated (see rationale for Recommendation 1) or cannot be tolerated by the patient. Intolerance by the patient can include refusal to wear the device or the patient’s circumstances do not support its use, such as unable to use the device as part of the patient’s job. A removable knee-high offloading device may be a solu- tion to these conditions.19 A removable knee-high device redistributes peak pressures in a similar fashion as a nonremovable knee-high device,6,10,19,33 although one study showed higher peak pressures during walking after a TCC was bivalved and made removable.66 A removable knee-high device also redistributes pressure more effec- tively than a removable ankle-high offloading device (such as ankle- high walker, forefoot offloading shoes, half shoes, cast shoes, or postoperative sandal).6,10,19,33

Our systematic review31 identified one high-quality meta- analysis,34 that included two low-quality RCTs,38,43 and found no dif- ference in the proportion of plantar forefoot ulcers healed between removable knee- and ankle-high offloading devices (healing sandal or half shoe) (P = 0.20).34 A more recent high-quality RCT also found no difference in plantar forefoot ulcers healed between a removable knee-high device (bivalved TCC) and either a removable ankle-high cast shoe or forefoot offloading shoe, at either 12 weeks (P = 0.703) or 20 weeks (P = 0.305).20 However, the authors noted the removable knee-high device group had significantly more deep ulcers (University

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