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; Wim Custers; Irma Paardekooper; Heleen A Berendsen; Sicco A Bus

doi:10.1371/journal.pone.0224010

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

PLoS One. 2020 Apr 23;15(4):e0224010. doi: 10.1371/journal.pone.0224010. eCollection 2020.

Authors

Jennefer B J Zwaferink¹, Wim Custers², Irma Paardekooper², Heleen A Berendsen³, Sicco A Bus¹

Affiliations

¹ Department of Rehabilitation Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.
² Penders Voetzorg, Delft, The Netherlands.
³ Department of Rehabilitation Medicine, Reinier de Graaf Gasthuis, Delft, The Netherlands.

Abstract

Aims: To assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration.

Methods: Twenty-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.

Results: All 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.

Conclusions: 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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Aged
Diabetic Foot / prevention & control
Diabetic Foot / rehabilitation*
Evidence-Based Practice
Female
Foot Orthoses / standards*
Humans
Male
Middle Aged
Patient Satisfaction
Pressure
Shoes / standards*

Grants and funding

An unrestricted grant from Penders Voetzorg and Choose Your Shoes, Heijthuijsen, the Netherlands, was provided for this study. Insole-B, marketed under the name DIABETEC® and manufactured by IETEC Orthopadische Einlagen GmbH, Künzell, Germany, and Insole- C, marketed under the name TrueContour® Therapeutic Insoles and manufactured by DIApedia, State College, Pennsylvania, USA, were provided for this study free of charge by the manufacturing companies. Insoles A, B and C were tested in the X-DIAB shoe, provided for this study free of charge by the manufacturer (Podartis Srl, Montebelluna, Italy). WK and IP are paid employees of Penders Voetzorg. None of these funders had any involvement in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.