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NCT06565156 · ClinicalTrials.gov registry record · NA
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
A NA study of Diabetic Foot Ulcer and Diabetic Foot, sponsored by BioStem Technologies.
- Active
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 17
- Study locations
NCT06565156 is a NA study of Diabetic Foot Ulcer and Diabetic Foot that is active but no longer recruiting, run by BioStem Technologies. The registered enrollment target is 72 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (72% lower). The trial reports 17 study locations across 10 states.
The verdict
NCT06565156, a NA study of Diabetic Foot Ulcer and Diabetic Foot, is active but no longer recruiting, sponsored by BioStem Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 17
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (72% lower). The listed sponsor is BioStem Technologies, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT06565156 reports 17 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Texas.
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.
What interventions are being tested in trial NCT06565156?
The interventions under investigation include: Standard Care (OTHER), BR-AM (OTHER).
Who is sponsoring clinical trial NCT06565156?
This trial is sponsored by BioStem Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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