Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

Abstract

Background Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers. Methods We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient‐reported measures, and cost‐effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non‐controlled studies were summarised on a narrative basis. Results We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta‐analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non‐controlled studies. Five meta‐analyses and 12 RCTs provided high‐quality evidence for non‐removable knee‐high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non‐removable knee‐high walkers were shown to be equally effective. Moderate‐quality evidence exists for removable knee‐high and ankle‐high offloading devices being equally effective in healing, but knee‐high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low‐quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non‐plantar ulcers, and neuropathic ulcers with infection or ischemia. Conclusion Strong evidence supports the use of non‐removable knee‐high offloading devices (either TCC or non‐removable walker) as the first‐choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee‐high or ankle‐high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high‐quality controlled studies are needed in these areas.

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

“…66 A removable knee-high device also redistributes pressure more effectively than a removable ankle-high offloading device (such as anklehigh walker, forefoot offloading shoes, half shoes, cast shoes, or postoperative sandal). 6,10,19,33 Our systematic review 31 identified one high-quality metaanalysis, 34 that included two low-quality RCTs, 38,43 and found no difference 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).…”

“…• Added a new recommendation on offloading treatments for people with neuropathic plantar heel ulcers. Our updated systematic review 31 identified five high-quality meta-analyses of controlled trials on this topic, [33][34][35][36][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 compared with removable devices (removable offloading devices or footwear).…”

“…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.…”

“…However, the previous guideline did not provide a recommendation on which one is preferable to use. 19 Our updated systematic review 31 identified one high-quality meta-analysis on this topic 34 that included three high-quality…”

State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy

“…International guidelines recommend the use of custom-made footwear to help prevent diabetic foot ulceration, with target pressures for footwear provided for those patients who healed from a plantar foot ulcer. [1][2][3][4][5] While the goals for custom-made footwear are clear and clinical decision-making in selecting the type of footwear is often defined by the degree of foot deformity present, footwear design can be variable and is hardly supported by any published protocol, shoe concept or algorithm. Only two consensus-based algorithms for custom-made footwear and a pressure-and foot shape-guided design algorithm for custom-made insoles have been identified in the scientific literature.…”