Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy (NCT07086443) | Clinical Trial Compass
RecruitingPhase 4
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
United States350 participantsStarted 2025-07-11
Plain-language summary
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Who can participate
Age range
18 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
. ABI between 0.7 and ≤ 1.3;
. TBI ≥ 0.6;
. TCOM ≥ 40 mmHg;
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.
1This trial is comparing different wound therapy approaches for diabetic foot ulcers — can you explain what 'exclusive wound therapy' means in this context, and how it differs from what I'm currently receiving?
2Since this is a Phase 4 trial, these treatments have already been approved and used before — does that mean the safety profile is better understood than in earlier-phase studies, and what side effects are still being monitored?
3The trial is measuring which arm gets more patients to complete wound closure — based on my specific ulcer size, location, and how long it has been open, do you think I'd have a reasonable chance of reaching that outcome?
4How often would I need to come in for wound assessments, and given the ongoing nature of diabetic foot ulcer care, would participating in this trial realistically fit with my current treatment schedule and life?
5If I don't join this trial, what standard-of-care options are available right now for a nonhealing diabetic foot ulcer like mine, and is there a reason to try one of those first before considering enrollment??
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.
What they're measuring
1
Between-arm difference in subjects achieving complete closure