Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers (NCT04791449) | Clinical Trial Compass
RecruitingNot Applicable
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
United States60 participantsStarted 2021-10-10
Plain-language summary
The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage).
Who can participate
Age range
20 Years – 80 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:
* diagnosis of type 2 diabetes
* 20 - 80 years of age
* Ankle-Brachial Index (ABI) \> 0.6 or Toe Pressure (TcPO2) \> 40 mmHg
* recent (within 12 weeks) blood glucose value between 100 - 350 mg/dL
* recent (within 12 weeks) HbA1c value \< 14 %,
* DFU of WIfI Grade 2 or less
* fluency in reading and speaking English or Spanish.
Exclusion Criteria:
* inability to provide own consent
* inability to obtain permission to participate from a medical professional
* lack of consistent mode of transportation to UNMH
* infection to any part of the body
* patients that has had a transplant and/or is immunocompromised
* prisoners.
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.