Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
Public ClinicalTrials.gov record NCT06811909. 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 Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06811909
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 71 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
- Feb 13, 2025
- Primary completion
- Jul 31, 2026
- Completion
- Sep 30, 2026
- Last update posted
- Aug 11, 2026
2025 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 8
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 17 | Guntersville | Alabama | 35976 | — |
| Site 2b | Castro Valley | California | 94546 | — |
| Site 19b | Glendale | California | 91204 | — |
| Site 36 | Oxnard | California | 93030 | — |
| Site 37 | Oxnard | California | 93036 | — |
| Site 19 | Palmdale | California | 93551 | — |
| Site 02 | San Francisco | California | 94115 | — |
| Site 2a | San Francisco | California | 94117 | — |
| Site 04 | Sylmar | California | 91342 | — |
| Site 30 | Torrance | California | 90502 | — |
| Site 01 | Vista | California | 92081 | — |
| Site 34 | Aventura | Florida | 33180 | — |
| Site 27 | Coral Gables | Florida | 33134 | — |
| Site 20 | Deerfield Beach | Florida | 33442 | — |
| Site 35 | Miami | Florida | 33126 | — |
| Site 31 | Miami | Florida | 33189 | — |
| Site 06 | O'Fallon | Illinois | 62269 | — |
| Site 18 | Boston | Massachusetts | 02118 | — |
| Site 32 | St Louis | Missouri | 63128 | — |
| Site 16 | Lake Success | New York | 11042 | — |
| Site 38 | Corpus Christi | Texas | 78414 | — |
| Site 03 | Fort Worth | Texas | 76104 | — |
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 NCT06811909, 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 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06811909 live on ClinicalTrials.gov.