Status:
COMPLETED
Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer
Lead Sponsor:
University of Michigan
Conditions:
Diabetic Foot Ulcer
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 di...
Detailed Description
Device Description: The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd. It is designed to reduce sliding friction and torque at the metatarsal heads in additio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01844479
Start Date
December 1 2012
End Date
January 1 2014
Last Update
October 6 2016
Active Locations (1)
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1
Michigan Orthotics and Prosthetics
Ann Arbor, Michigan, United States, 48104-6768