Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
NCT06811909 · View on ClinicalTrials.gov ↗
Study Summary
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone. This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.
Conditions Studied
Interventions
- OTHER Standard Care
- OTHER BR-AC
Study Locations (20)
California
- Site 2b — Castro Valley
- Site 19b — Glendale
- Site 36 — Oxnard
- Site 37 — Oxnard
- Site 19 — Palmdale
- Site 02 — San Francisco
- Site 2a — San Francisco
- Site 04 — Sylmar
- Site 30 — Torrance
- Site 01 — Vista
Florida
- Site 34 — Aventura
- Site 27 — Coral Gables
- Site 20 — Deerfield Beach
- Site 33 — Fort Walton Beach
- Site 35 — Miami
- Site 31 — Miami
Alabama
- Site 17 — Guntersville
Illinois
- Site 06 — O'Fallon
Massachusetts
- Site 18 — Boston
Missouri
- Site 32 — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2026-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06811909
The ClinicalTrials.gov registry entry for NCT06811909 describes a study currently listed as 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 60 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 Venous Leg 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: NCT06811909 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT06811909 about?
NCT06811909 is a clinical study titled "Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC". This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VL...
What is the current status of trial NCT06811909?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-02-14. Estimated completion is 2026-10.
What conditions does trial NCT06811909 study?
This clinical trial studies the following conditions: Venous Leg Ulcer, Venous Insufficiency, Venous Stasis, Venous Reflux, Non-infected Venous Leg 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 NCT06811909?
The interventions under investigation include: Standard Care (OTHER), BR-AC (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06811909?
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 NCT06811909 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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