Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05603273
Status
Recruiting
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Conditions

  • Foot Ulcer
  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • non-weight bearing exercise — BEHAVIORAL
    exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks

Study Details

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

Key Dates

Start date
Dec 13, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: standard wound care
    normal wound care according to current clinical practice
  • Experimental: non-weight bearing exercise + standard wound care
    normal wound care according to current clinical practice with the addition of a weekly exercise routine

Primary Outcome Measure

wound size and depth [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
School of KinesiologyAnn ArborMichigan48109
Jacob Haus, PhD
[email protected]
734 763 3932

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By research site
School of Kinesiology· Ann Arbor, MI

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