Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer, Diabetic Foot

In brief

In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.

Key facts

Study ID

NCT01844479

Run by

University of Michigan

People needed

27

Starts

2012-12-01

Expected to finish

2014-01-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be included if they have diabetes and have been referred for diabetic shoes. They will also be insensate with pre-ulcerative plantar callus or previous plantar foot ulcer.

You may not qualify if…

• Patients will be excluded if they are unable to independently walk 100 feet, lower extremity prosthesis user, have active cellulitis, foot ulcer, or Charcot foot.

Where it is running

• Michigan Orthotics and Prosthetics — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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