A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
BioStem Technologies
Summary
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.
Description
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care only in the treatment of venous leg ulcers. The eligibility criteria for this study will allow for enrollment of subjects with a VLU in the range of 2 cm\^2 to 20 cm\^2 in area. A lower size of 2 cm\^2 was selected to exclude subjects who are likely to heal under compression therapy alone. During the two-week run-in period, subjects who show a reduction in wound area predictive of achieving complete wound closure within 12 weeks under st…