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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or Female, aged 18 yrs or older

Diabetes diagnosed or meets ADA criteria for Type 2 diabetes

Disqualifiers

Patient participating in an interventional clinical trial within 1 month of visit 1

Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading

Participant has active severe infection or osteomyelitis at the time of the screening visit

History of cancer within the last 3 years, other than non-melanoma skin cancer

Trial design

Treatments tested in this trial

  • non-weight bearing exercise

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators