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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

Erin E. Klein, DPM, MS ^*, Ryan T. Crews, MS ^* , Stephanie C. Wu, DPM, MS ^* , James S. Wrobel, DPM, MS ^*  and David G. Armstrong, DPM, PhD ^* 

^* Scholl’s Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, North Chicago, IL.
North Chicago Veterans Affairs Medical Center, North Chicago, IL.

Corresponding author: Erin Klein, DPM, MS, Scholl’s CLEAR, 3333 Green Bay Rd, North Chicago, IL 60064. (E-mail: eklein27.dpm{at}gmail.com)

Abstract

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. (J Am Podiatr Med Assoc 98(4): 261–267, 2008)