60
Participants
Start Date
October 28, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
January 31, 2026
BR-AM
BR-AM is a single-layer amniotic membrane allograft. BR-AM 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 of care is defined as:~* Debridement,~* Wound cleansing with a neutral, non-irritating and non-toxic solution,~* Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and~* An off-loading device."
RECRUITING
Site 16, Lake Success
RECRUITING
Site 15, Chapel Hill
RECRUITING
Site 28, DeLand
RECRUITING
Site 27, Coral Gables
RECRUITING
Site 20, Deerfield Beach
RECRUITING
Site 17, Guntersville
RECRUITING
Site 26, Detroit
RECRUITING
Site 23, Springfield
RECRUITING
Site 21, Burleson
RECRUITING
Site 24, San Antonio
RECRUITING
Site 29, Brownsville
RECRUITING
Site 22, Mesa
RECRUITING
Site 25, Tucson
RECRUITING
Site 01, Vista
RECRUITING
Site 19, Palmdale
RECRUITING
Site 02, San Francisco
RECRUITING
Site 18, Boston
Lead Sponsor
BioStem Technologies
INDUSTRY