Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment o… (NCT07290673) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
United States124 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment.
One ulcer on each participant's foot will receive weekly applications of 1) FoundationDRS Solo and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
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
. 1\. Subjects must be at least 18 years of age or older.
. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy.
. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement prior to randomization at treatment visit 1 (TV1).
. The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care.
. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below either malleoli.
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.
What they're measuring
1
Incidence of Complete Wound Closure
Timeframe: 12-weeks following study screening phase
. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
. ABI between 0.7 and ≤ 1.3;
Exclusion criteria
. The index ulcer has been offloaded with protocol defined offloading device for at least 14 days prior to randomization (i.e. Screening through TV1/Randomization).
0. The potential subject must consent to using the prescribed offloading method for the duration of the study.
1. The potential subject must agree to attend the weekly study visits required by the protocol.
2. The potential subject must be willing and able to participate in the informed consent process.
3. Index ulcer and/or index ulcer limb may have had prior infection(s), but must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1 (Appendix L).
4. The index ulcer has a clean base and is free from necrotic debris at time of placement of product / treatment.
5. Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one yar or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
. The target ulcer has been present for more than 52 weeks.