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NCT06811909 · ClinicalTrials.gov registry record · NA
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
A NA study of Venous Leg Ulcer and Venous Insufficiency, sponsored by BioStem Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT06811909: Recruiting NA study of Venous Leg Ulcer and Venous Insufficiency, sponsored by BioStem Technologies.
NCT06811909 is a NA study of Venous Leg Ulcer and Venous Insufficiency that is actively recruiting participants, run by BioStem Technologies. The registered enrollment target is 60 participants, below the 243-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06811909, a NA study of Venous Leg Ulcer and Venous Insufficiency, is actively recruiting participants, sponsored by BioStem Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
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 |
What NCT06811909 shows while recruiting
NCT06811909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 243-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (75% lower).
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.
NCT06811909 names 20 study sites across 6 states, led by California, Florida, Alabama.
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.
What interventions are being tested in trial NCT06811909?
The interventions under investigation include: Standard Care (OTHER), BR-AC (OTHER).
Who is sponsoring clinical trial NCT06811909?
This trial is sponsored by BioStem Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06811909's enrollment target sits among peer trials
60 28th of 35 higher than 8 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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