Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers (NCT07290673)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (14 items).
Location: Alma Medical and Research Services — Hollywood, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- The target ulcer has been present for more than 52 weeks.
- The ulcer includes exposed tendon or bone.
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or has cellulitis in the surrounding skin.
- There is evidence of osteomyelitis complicating the target ulcer.
- The potential subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has a previous partial amputation on the affected foot that resulted in a deformity impeding proper offloading of the target ulcer.
- A potential subject must be excluded if either of the following conditions are met: Condition A (Overall 4-week reduction) The surface are of the target ulcer has decreased by more than 50% over the 4 weeks prior to Treatment Visit 1, which includes: The historical run-in period, and The 2-week Screening Phase. OR Condition B (Sequential reductions across both phases) Both of the following are true:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Alma Medical and Research Services — Hollywood, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.