Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
NCT06565156 · View on ClinicalTrials.gov ↗
Study Summary
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and offloading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AM product following the protocol and procedures set forth within this document.
Conditions Studied
Interventions
- OTHER Standard Care
- OTHER BR-AM
Study Locations (17)
California
- Site 19 — Palmdale
- Site 02 — San Francisco
- Site 01 — Vista
Florida
- Site 27 — Coral Gables
- Site 20 — Deerfield Beach
- Site 28 — DeLand
Texas
- Site 29 — Brownsville
- Site 21 — Burleson
- Site 24 — San Antonio
Arizona
- Site 22 — Mesa
- Site 25 — Tucson
Alabama
- Site 17 — Guntersville
Illinois
- Site 23 — Springfield
Massachusetts
- Site 18 — Boston
Michigan
- Site 26 — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2026-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06565156
The ClinicalTrials.gov registry entry for NCT06565156 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioStem Technologies, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions — of which Standard Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06565156 reports 17 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06565156 about?
NCT06565156 is a clinical study titled "Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM". This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affec...
What is the current status of trial NCT06565156?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2024-10-28. Estimated completion is 2026-06.
What conditions does trial NCT06565156 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Diabetic Foot, Non-infected Diabetic Foot Ulcer, Diabetic Wound, Non-ischemic Diabetic Foot Ulcer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06565156?
The interventions under investigation include: Standard Care (OTHER), BR-AM (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06565156?
This trial is sponsored by BioStem Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06565156 being conducted?
This trial has 17 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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