Abstract

The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration in people with diabetic peripheral neuropathy. We searched multiple databases for published and unpublished studies reporting offloading footwear and insoles for people with diabetic neuropathy and nonulcerated feet. Primary outcome was foot ulcer incidence; other outcome measures considered were any standardized kinetic or kinematic measure indicating loading or offloading the plantar foot. Fifty‐four studies, including randomized controlled studies, cohort studies, case‐series, and a case‐controlled and cross‐sectional study were included. Three meta‐analyses were conducted and random‐effects modelling found peak plantar pressure reduction of arch profile (37 kPa (MD, −37.5; 95% CI, −72.29 to −3.61; P < .03), metatarsal addition (35.96 kPa (MD, −35.96; 95% CI, −57.33 to −14.60; P < .001) and pressure informed design 75.4 kPa (MD, −75.4 kPa; 95% CI, −127.4 to −23.44 kPa; P < .004).The remaining data were presented in a narrative form due to heterogeneity. This review highlights the difficulty in differentiating the effect of different insole and footwear features in offloading the neuropathic diabetic foot. However, arch profiles, metatarsal additions and apertures are effective in reducing plantar pressure. The use of pressure analysis to enhance the effectiveness of the design of footwear and insoles, particularly through modification, is recommended.

Highlights

  • Foot ulceration is amongst the most serious complications of diabetes mellitus 1

  • We excluded studies on people with active ulceration, major amputation of the foot or Charcot arthropathy because we considered that the unique patho-mechanics and gross deformity associated with the severity of these conditions would unduly influence the design features of the footwear and insoles

  • Identification of specific design features of footwear and insoles related to the primary outcome measure of foot ulceration was not possible

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Summary

Introduction

Foot ulceration is amongst the most serious complications of diabetes mellitus 1. It is expected that 19-34% of people with diabetes will develop a foot ulcer at some point 2. Prevention of foot ulceration occurrence and reoccurrence are recognised as key strategies in reducing the concomitant burden to patients with diabetes and the healthcare system 8. Elevated dynamic plantar pressures during locomotion contribute to the development of plantar diabetic foot ulcers when in the presence of neuropathy 11,12. Systematic reviews have demonstrated the effectiveness of footwear and insoles in offloading the plantar load under the foot and preventing ulceration 14-18. These have not identified the best insole design or feature and footwear specification or modification for use when reducing plantar load for foot ulcer prevention in people with diabetes and neuropathy

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