Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers (NCT05603273) | Clinical Trial Compass
RecruitingNot Applicable
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
United States40 participantsStarted 2023-12-13
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Foot ulcer of diabetic etiology, with all of the following characteristics:
. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Use of adjunctive therapy within previous 30 days
. Currently receiving medication considered to be a systemic glucocorticoid
. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention