Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review

BACKGROUND: In people with diabetes, offloading high-risk foot regions by optimising footwear, or insoles, may prevent ulceration. This systematic review aimed to summarise and evaluate the evidence for footwear and insole features that reduce pathological plantar pressures and the occurrence of diabetic neuropathy ulceration at the plantar forefoot in people with diabetic neuropathy. METHODS: Six electronic databases (Medline, Cinahl, Amed, Proquest, Scopus, Academic Search Premier) were searched in July 2019. The search period was from 1987 to July 2019. Articles, in English, using footwear or insoles as interventions in patients with diabetic neuropathy were reviewed. Any study design was eligible for inclusion except systematic literature reviews and case reports. Search terms were diabetic foot, physiopathology, foot deformities, neuropath*, footwear, orthoses, shoe, footwear prescription, insole, sock*, ulcer prevention, offloading, foot ulcer, plantar pressure. RESULTS: Twenty-five studies were reviewed. The included articles used repeated measure (n = 12), case-control (n = 3), prospective cohort (n = 2), randomised crossover (n = 1), and randomised controlled trial (RCT) (n = 7) designs. This involved a total of 2063 participants. Eleven studies investigated footwear, and 14 studies investigated insoles as an intervention. Six studies investigated ulcer recurrence; no study investigated the first occurrence of ulceration. The most commonly examined outcome measures were peak plantar pressure, pressure-time integral and total contact area. Methodological quality varied. Strong evidence existed for rocker soles to reduce peak plantar pressure. Moderate evidence existed for custom insoles to offload forefoot plantar pressure. There was weak evidence that insole contact area influenced plantar pressure. CONCLUSION: Rocker soles, custom-made insoles with metatarsal additions and a high degree of contact between the insole and foot reduce plantar pressures in a manner that may reduce ulcer occurrence. Most studies rely on reduction in plantar pressure measures as an outcome, rather than the occurrence of ulceration. There is limited evidence to inform footwear and insole interventions and prescription in this population. Further high-quality studies in this field are required.