Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
Public ClinicalTrials.gov record NCT06565156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06565156
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2024
- Primary completion
- Nov 13, 2025
- Completion
- Apr 29, 2026
- Last update posted
- Aug 11, 2026
2024 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 17 | Guntersville | Alabama | 35976 | — |
| Site 22 | Mesa | Arizona | 85206 | — |
| Site 25 | Tucson | Arizona | 85723 | — |
| Site 19 | Palmdale | California | 93551 | — |
| Site 02 | San Francisco | California | 94115 | — |
| Site 01 | Vista | California | 92081 | — |
| Site 27 | Coral Gables | Florida | 33134 | — |
| Site 20 | Deerfield Beach | Florida | 33442 | — |
| Site 28 | DeLand | Florida | 32720 | — |
| Site 23 | Springfield | Illinois | 62704 | — |
| Site 18 | Boston | Massachusetts | 02118 | — |
| Site 26 | Detroit | Michigan | 48201 | — |
| Site 16 | Lake Success | New York | 11042 | — |
| Site 15 | Chapel Hill | North Carolina | 27599 | — |
| Site 29 | Brownsville | Texas | 78520 | — |
| Site 21 | Burleson | Texas | 76028 | — |
| Site 24 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06565156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06565156 live on ClinicalTrials.gov.