Table 2 Study characteristics of selected articles for ulcer recurrence as the primary outcome measure
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 Neuropathy 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 Neuropathy 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 Neuropathy PVD 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 Neuropathy 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 Neuropathy 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. |