NCT06811909

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

A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: BioStem Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 standardized care alone (i.e., compression therapy) will be excluded from the study. Eliminating these subjects will improve the estimated treatment effect. The criteria for duration, ≥ 4 weeks but ≤ 52 weeks, allows for the selection of those wounds that have demonstrated chronicity but may still have the potential to achieve wound closure. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for evaluating venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence, debridement, and compression therapy. Weekly subject visits will help monitor compliance in wound care and compression therapy, as well as to document when wound closureis achieved. The study will implement the use of an electronic imaging and measurement device (eKare inSight®) using a standardized protocol to ensure the measuring of the wound surface area is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to SOC only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up period will consist of a four-week follow-up with two visits at each two-week interval.

Conditions

• Non-infected Venous Leg Ulcer
• Venous Leg Ulcer
• Venous Insufficiency
• Venous Stasis
• Venous Reflux

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-02-06
• Last updated: 2026-01-23

Locations

23 sites across 1 country: United States