State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy.

Supported by evidence-based guidelines, custom-made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom-made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate-to-high risk of developing a foot ulcer, for whom custom-made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face-to-face meetings to develop a footwear design algorithm and evidence-based pressure-relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe-specific and insole (orthosis)-specific features were defined. Most insole-related features and some shoe-related features were evidence based, whereas most shoe-related features were consensus based. The pressure-relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure-relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate-to-high-risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers.