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Preliminary Evaluation of a Cycling Cleat Designed for Diabetic Foot Ulcers

Ryan T. Crews Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, Center for Lower Extremity Ambulatory Research (CLEAR), North Chicago, IL.

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Steven R. Smith HealthPartners Institute for Education and Research at Regions Hospital, St. Paul, MN.

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Ramin Ghazizadeh Vangard Weiss Memorial Hospital, Chicago, IL.

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Sai V. Yalla Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, Center for Lower Extremity Ambulatory Research (CLEAR), North Chicago, IL.

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Stephanie C. Wu Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, Center for Lower Extremity Ambulatory Research (CLEAR), North Chicago, IL.
Department of Surgery, Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, North Chicago, IL.

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Background:

Offloading devices for diabetic foot ulcers (DFU) generally restrict exercise. In addition to traditional health benefits, exercise could benefit DFU by increasing blood flow and acting as thermotherapy. This study functionally evaluated a cycling cleat designed for forefoot DFU.

Methods:

Fifteen individuals at risk of developing a DFU used a recumbent stationary bicycle to complete one 5-minute cycling bout with the DFU cleat on their study foot and one 5-minute bout without it. Foot stress was evaluated by plantar pressure insoles during cycling. Laser Doppler perfusion monitored blood flow to the hallux. Infrared photographs measured foot temperature before and after each cycling bout.

Results:

The specialized cleat significantly reduced forefoot plantar pressure (9.9 kPa versus 62.6 kPa, P < .05) and pressure time integral (15.4 versus 76.4 kPa*sec, P < .05). Irrespective of footwear condition, perfusion to the hallux increased (3.97 ± 1.2 versus 6.9 ± 1.4 tissue perfusion units, P < .05) after exercise. Infrared images revealed no changes in foot temperature.

Conclusions:

The specialized cleat allowed participants to exercise with minimal forefoot stress. The observed increase in perfusion suggests that healing might improve if patients with active DFU were to use the cleat. Potential thermotherapy for DFU was not supported by this study. Evaluation of the device among individuals with active DFU is now warranted.

Corresponding author: Ryan T. Crews, MS, Rosalind Franklin University of Medicine and Science, Dr. William M. Scholl College of Podiatric Medicine, Center for Lower Extremity Ambulatory Research (CLEAR), 3333 Green Bay Road, North Chicago, IL. (E-mail: ryan.crews@rosalindfranklin.edu)