Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers (NCT07290673)
A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Foundation DRS Solo as an Adjunct to Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
🩺 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: Review the eligibility criteria below.
Location: Alma Medical and Research Services — Hollywood, Florida
Age range: 18 Years
🧪 Interventions in This Study
- FoundationDRS Solo (OTHER)
- Standard of Care (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Alma Medical and Research Services — Hollywood, Florida
📞 Contact the Study Coordinator
Phone: (484) 883-2033
Email: jmercuri@samaritanbiologics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Diabetic Foot Ulcer (DFU)
- Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU — Colorado Springs, Colorado
- Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers — North Port, Florida
- HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU — Novi, Michigan
- Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing — Chicago, Illinois
- CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations — Oxnard, California
Explore by condition: All Diabetic Foot Ulcer (DFU) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.