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Table 2 Study characteristics of selected articles for ulcer recurrence as the primary outcome measure

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

Author, date Location Study design Follow up period Sample size Sample characteristics Intervention & Comparison Outcome measures Result
Busch et al. 2003 [56] Germany Prospective cohort Up to 42 months 92 Diabetes
Peripheral vascular disease (PVD)
Lucro SDS vs non-SDS standard footwear Ulcer recurrence Annual ulcer recurrence SDS 15% vs Non-SDS 60% when severe foot deformity is non-existent
Bus et al. 2013 [57] Netherlands RCT 18 months 171 Diabetes
Healed plantar ulcers
Custom-made footwear with and without modifications based on in-shoe pressure analysis Ulcer recurrence Adherence of ≥80% steps taken Modified custom-made footwear are only useful in offloading forefoot area if they are worn as per advised (Adherence ≥80%)
Chantelau et al. 1990 [58] Germany Prospective cohort 25 months 50 Diabetes
History of healed plantar foot ulcer
Partial or forefoot amputation
Custom-made footwear with rocker soles and custom-made insoles with 10 mm thickness, Ulcer recurrence
Adherence (regular vs irregular wearing of footwear and insoles)
Regular wearing of footwear and insoles reduced the relative risk of foot ulceration to 0.48 (95% confidence interval 0.29 to 0.79), compared with irregular wearing
Lavery et al. 2012 [59] USA RCT 18 months 299 Diabetes
Healed foot ulcers
Foot deformity
Shear reducing insole (SRI) with standard therapy group (STG) with therapeutic footwear, diabetic foot education and care Ulcer recurrence SRI group were 3.5 times less likely to develop foot ulcers comparing to the STG group. No significant difference in the frequency of footwear and insole usage in SRI or STG group.
López-Moral et al. 2019 [60] Italy RCT 18 months 51 Diabetes
Healed plantar ulcers
Semi-rigid (control) and rigid rocker sole (test) therapeutic footwear Ulcer recurrence Adherence > 60% Rigid rocker sole can reduce risk of re-ulceration at forefoot by 64% compared to semi-rigid rocker sole
Rizzo et al. 2012 [61] Italy RCT 5 years 298 Diabetes
Neuropathy Healed plantar foot ulcer
Minor amputation
Standard comfort footwear vs custom insoles and footwear as per Dahmen et al. algorithm Ulcer recurrence Ulcer recurrence rates in 1, 3 & 5 years are 11.5% vs 38.6, 17.6% vs 61, 23.5% vs 72% where forefoot deformities are predominant among the participants.
Ulbrecht et al. 2014 [62] USA RCT 15 months 150 Diabetes
Neuropathy Healed plantar foot ulcer (MTHs)
Increased barefoot plantar pressure
Control: Standard custom-made insoles from three different suppliers
Experimental: Insoles made according to the protocol in Owings et al. 2008.
Ulcerative or non-ulcerative lesions at the plantar forefoot in MTHs regions Foot shape and plantar pressure-based custom insoles provide superior offloading than insoles made from foot shape and clinical insights.
  1. MP Metatarsal Pad, MB Metatarsal Bar, MD Metatarsal Dome, SDS Stock Diabetic Shoes, MTH1 First Metatarsal Head, FTI Force Time Integral, PTI Pressure Time Integral, MPP Mean Peak Pressure, TCI Total Contact Insoles, SRI Shear Reducing Insoles, STG Standard Therapy Group