A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without 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 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."