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Study identifier: NCT06811909 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Condition: Non-infected Venous Leg Ulcer · Venous Leg Ulcer · Venous Insufficiency  ·  Sponsor: BioStem Technologies

PhaseNA
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nick McCoy  ·  2144571996  ·  nmccoy@biostemtech.com

Always discuss trial participation with your own doctor first.

Locations (23)

Site 17Guntersville, Alabama, United StatesRecruiting
Site 2bCastro Valley, California, United StatesRecruiting
Site 19bGlendale, California, United StatesRecruiting
Site 36Oxnard, California, United StatesRecruiting
Site 37Oxnard, California, United StatesRecruiting
Site 19Palmdale, California, United StatesRecruiting
Site 02San Francisco, California, United StatesRecruiting
Site 2aSan Francisco, California, United StatesRecruiting
Site 04Sylmar, California, United StatesRecruiting
Site 30Torrance, California, United StatesRecruiting
Site 01Vista, California, United StatesRecruiting
Site 34Aventura, Florida, United StatesRecruiting

+ 11 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06811909