title: 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: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Scholl's Center for Lower Extremity Ambulatory Research (CLEAR), Rosalind Franklin University of Medicine and Science, North Chicago, IL 60064, USA. eklein27.dpm@gmail.com
authors.forename: Erin E
authors.initials: EE
authors.lastname: Klein
authors.forename: Ryan T
authors.initials: RT
authors.lastname: Crews
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Wu
authors.forename: James S
authors.initials: JS
authors.lastname: Wrobel
authors.forename: David G
authors.initials: DG
authors.lastname: Armstrong
mesh_terms: D000328:Adult; D001642:Bicycling; D017719:Diabetic Foot / Q000534:rehabilitation*; D004389:Durable Medical Equipment; D015444:Exercise; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D010865:Pilot Projects; D011312:Pressure; D012775:Shoes