CLEAR Cleat: A Proof-of-Concept Trial of an Aerobic Activity Facilitator to Reduce Plantar Forefoot Pressures and Their Potential in Those with Foot Ulcers

Abstract

Exercise has not been studied extensively in persons with active neuropathic diabetic foot wounds, primarily because a device does not exist that allows patients to exercise while sufficiently off-loading pressure at the ulcer site. The purpose of this project was to demonstrate a device that reduces cycling plantar forefoot pressure. Ten healthy participants rode a recumbent bicycle under three cycling conditions. While the left foot interaction remained constant with a standard gym shoe and pedal, the right foot was exposed to a control condition with standard gym shoe and pedal, gym shoe and specialized cleat, and gym shoe with an off-loading insole and specialized cleat. Pressure and contact area of the plantar aspect of the feet were recorded for a 10-sec interval once during each minute of each condition's 7-min trial. The off-loading insole and specialized cleat condition yielded significantly lower (P < .01) peak pressure, contact area, and pressure-time integral values in the forefoot than the specialized cleat condition with gym shoe, which yielded significantly lower values (P < .01) than the standard gym shoe and pedal. Modifications to footwear may alter plantar forefoot pressures, contact area, and pressure-time integrals while cycling. The CLEAR Cleat could play a significant role in the facilitation of fitness in patients with (or at high risk for) neuropathic wounds.