Evaluating Foot Pressure and Comfort of LEEF-shoe Versus Standard Orthopedic Shoes in Adults with Diabetes and Neuropathy

What this Trial Is About

This research aims to compare the LEEF-shoe with standard orthopedic shoes in adults with diabetes mellitus and peripheral neuropathy who are at increased risk for foot ulcers. The study focuses on whether the LEEF-shoe differs from standard shoes in how it distributes pressure on the foot, which is important as foot ulcers can lead to serious complications like amputation. The trial also looks at how long participants wear each shoe and how much they accept and like the footwear. Participants will receive two pairs of orthopedic shoes the standard shoe and the LEEF-shoe, both provided through usual care. They will wear each shoe type for four weeks in a randomized order while their wearing time is continuously monitored. After eight weeks, pressure measurements are repeated and participants can choose which shoe to wear for an additional four weeks, during which wearing time continues to be recorded. The LEEF-shoe uses a standardized protocol to set the shoes rocker design to potentially improve comfort and pressure relief compared to conventional shoes. During the study, researchers will measure peak plantar pressure at several points, wearing time, shoe and body measurements, and gather feedback through focus group sessions on user experience and acceptance. Participants will attend appointments for shoe fitting, pressure measurement, and follow-up visits. The study lasts a total of 12 weeks, including the free-choice period, and aims to ensure safety by comparing the new shoe type to standard care footwear.

Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy