60
Participants
Start Date
February 14, 2025
Primary Completion Date
August 31, 2026
Study Completion Date
October 31, 2026
BR-AC
BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.
Standard Care
"Standard Care is defined as:~* Sharp debridement,~* Wound cleansing with a neutral, non-irritating and non-toxic solution,~* Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and~* The UrgoK2™ dual compression system providing around 40 mmHg."
RECRUITING
Site 16, Lake Success
RECRUITING
Site 33, Fort Walton Beach
RECRUITING
Site 35, Miami
RECRUITING
Site 27, Coral Gables
RECRUITING
Site 34, Aventura
RECRUITING
Site 31, Miami
RECRUITING
Site 20, Deerfield Beach
RECRUITING
Site 17, Guntersville
RECRUITING
Site 06, O'Fallon
NOT_YET_RECRUITING
Site 32, St Louis
RECRUITING
Site 03, Fort Worth
RECRUITING
Site 30, Torrance
RECRUITING
Site 19b, Glendale
RECRUITING
Site 04, Sylmar
RECRUITING
Site 01, Vista
RECRUITING
Site 36, Oxnard
RECRUITING
Site 37, Oxnard
RECRUITING
Site 19, Palmdale
RECRUITING
Site 02, San Francisco
RECRUITING
Site 2a, San Francisco
RECRUITING
Site 2b, Castro Valley
RECRUITING
Site 18, Boston
Lead Sponsor
BioStem Technologies
INDUSTRY