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

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.