Optimizing footwear for the diabetic foot: Data-driven custom-made footwear concepts and their effect on pressure relief to prevent diabetic foot ulceration.

Jennefer B J Zwaferink,Irma Paardekooper,Sicco A Bus,Wim Custers,Heleen A Berendsen,Yih-Kuen Jan

doi:10.1371/journal.pone.0224010

Jennefer B J Zwaferink, Irma Paardekooper + Show 4 more

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https://doi.org/10.1371/journal.pone.0224010

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Abstract

AimsTo assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration.MethodsTwenty-four neuropathic diabetic patients at high risk of foot ulceration were measured for in-shoe plantar pressures during walking in four data-driven custom-made footwear conditions, an athletic shoe and an off-the-shelf non-therapeutic shoe. Two evidence-based footwear conditions (Shoe-A; Insole-A) follow a scientific-based design protocol, are handmade, and use in-shoe plantar pressure guided optimization. One evidence-based insole condition (Insole-B) uses a barefoot plantar pressure and 3D foot shape-based computer-assisted design and manufacturing (CADCAM) routine. And one insole condition (Insole-C) uses a barefoot and in-shoe plantar pressure and 3D foot shape-based CADCAM design and optimization routine. Patient satisfaction was scored on walking comfort, shoe fit, weight and appearance.ResultsAll data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17–53% relief). Shoe-A and Insole-A showed the lowest metatarsal head peak pressures (mean 112–155 kPa, 90–98% of cases <200 kPa), significantly lower than for Insole-B and Insole-C (mean 119–199 kPa, 52–100% <200 kPa). Patient satisfaction was not significantly different between footwear concepts.ConclusionsThis study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention.

Highlights

Foot ulceration often occurs as late complication in persons with diabetes mellitus; lifetime incidence has been estimated at 19–34% [1]
All data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17–53% relief)
This study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention

Summary

Introduction

Foot ulceration often occurs as late complication in persons with diabetes mellitus; lifetime incidence has been estimated at 19–34% [1]. To prevent ulcer recurrence, the International Working Group on the Diabetic Foot 2015 guideline and the more recent Dutch and Australian 2017 guidelines recommend the use of custom-made footwear with a demonstrated peak plantar pressure relieving effect of at least 30% compared with usual care or recently worn therapeutic (custom-made) footwear [4,5,6] To achieve this target in pressure relief, several data-driven custom-made footwear concepts have been developed. Another concept uses 3D foot shape and barefoot plantar pressure data as input to a design algorithm from which through computer-assisted design and manufacturing (CADCAM) a custom-made insole is created [11] These insoles significantly relieve peak pressure by approximately 30% and a randomized controlled trial showed that they reduce the incidence of plantar metatarsal head (MTH) ulcer recurrence compared to traditional, only shape-based, custom-made insole designs [11,12]. Proof of principle and clinical efficacy of this insole concept have not yet been reported

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