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

Background: 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. Methods: 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. Results: 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. Conclusion: 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.