A proof‐of‐concept study of the effectiveness of a removable device for offloading in patients with neuropathic ulceration of the foot: the Ransart boot

Diabetes Metabolism Res

Armstrong

Deursen

et al. 2016

175

196

RecommendationsCasting and prefabricated healing devices 1. To heal a neuropathic plantar forefoot ulcer without ischemia or uncontrolled infection in a patient with diabetes, offload with a non-removable knee-high device with an appropriate foot-device interface. (GRADE strength of recommendation: strong, Quality of evidence: high) 2. When a non-removable knee-high device is contraindicated or not tolerated by the patient, consider offloading with a removable knee-high walker with an appropriate foot-device interface to heal a neuropathic plantar forefoot ulcer in a patient with diabetes, but only when the patient can be expected to be adherent to wearing the device. (Weak; Moderate) 3. When a knee-high device is contraindicated or cannot be tolerated by the patient, consider offloading with a forefoot offloading shoe, cast shoe, or custom-made temporary shoe to heal a neuropathic plantar forefoot ulcer in a patient with diabetes, but only when the patient can be expected to be adherent to wearing the shoes. (Weak; Low) Therapeutic footwear4. To protect their feet, instruct an at-risk patient with diabetes not to walk barefoot, in socks only, or in thin-soled standard slippers, whether at home or when outside. (Strong; Low) 5. Instruct an at-risk patient with diabetes to wear properly fitting footwear to prevent a first foot ulcer, either plantar or non-plantar, or a recurrent nonplantar ulcer. When a foot deformity or a pre-ulcerative sign is present, consider prescribing therapeutic shoes, custom-made insoles, or toe orthosis. (Strong; Low) 6. To prevent a recurrent plantar foot ulcer in an at-risk patient with diabetes, prescribe therapeutic footwear that has a demonstrated plantar pressurerelieving effect during walking (i.e. 30% relief compared with plantar pressure in standard of care therapeutic footwear) and encourage the patient to wear this footwear. (Strong; Moderate) 7. Do not prescribe, and instruct a patient with diabetes not to use, conventional or standard therapeutic shoes to heal a plantar foot ulcer. (Strong; Low) 8. Consider using shoe modifications, temporary footwear, toe spacers, or

Section: Casting and Prefabricated Healing Devicesmentioning

confidence: 78%

IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes

Diabetes Metabolism Res

Armstrong

Deursen

et al. 2016

175

196

“…Several noncontrolled studies show that 70% to 96% of plantar foot ulcers can be healed in a reasonable time frame (mean 34‐79 d) with ankle‐high removable offloading devices, provided they are used regularly . Multiple cross‐sectional studies also consistently found that a variety of removable ankle‐high offloading devices were more effective in reducing plantar pressure at the forefoot than a variety of footwear interventions (custom‐made, therapeutic, extra‐depth, conventional, or standard footwear) .…”

Section: Recommendationsmentioning

confidence: 99%

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

Diabetes Metabolism Res

Armstrong

Gooday

et al. 2020

179

432

The International Working Group on the Diabetic Foot (IWGDF) has published evidence‐based guidelines on the prevention and management of diabetic foot disease 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 benefits 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 recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment 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 neuropathic 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.

“…Half-shoes, forefoot off-loading shoes, and cast shoes may be effective in healing neuropathic forefoot ulcers (healing proportions, 58%-91%), although their efficacy requires confirmation in prospective trials. 34,[51][52][53][54] Conventional or standard therapeutic footwear is not effective in ulcer healing, and the role of custom footwear in this context is not yet clear. 55 Several prospective controlled studies have shown that surgical interventions such as Achilles tendon lengthening, metatarsal-phalangeal joint arthroplasty, and metatarsal head resection may have only limited additional value in ulcer healing compared with conservative treatment.…”

Section: The Evidence Base: What Work and What Does Not Work?mentioning

confidence: 99%

Off-loading the diabetic foot for ulcer prevention and healing

Cavanagh

Journal of Vascular Surgery

2010

145