A Multi-Center Randomized Trial Comparing NuShield4 Plus Standard Care to Standard Care Alone for Treating Non-Healing Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating the use of NuShield4, a dehydrated placental allograft, combined with standard care compared to standard care alone for treating non-healing venous leg ulcers VLUs. This prospective, multi-center, randomized controlled trial aims to gather outcome data on wound healing effectiveness in adults with VLUs. The study is sponsored by Organogenesis and focuses on ulcers that have not healed with conventional treatment. Participants will be randomly assigned to receive either NuShield4 plus standard care or standard care alone. Standard care includes standard compression therapy and wound management. The study measures include the proportion of subjects achieving complete wound closure by 16 weeks, with secondary outcomes assessing closure by 12 weeks, time to closure, and percentage reduction in wound area. Weekly study visits will support treatment and monitoring. During the trial, participants will attend weekly visits for wound assessment and treatment. Researchers will evaluate wound healing progress using clinical evaluations and document outcomes like total wound closure and wound size reduction. The study requires participants to comply with all visits and procedures, including informed consent and contraception use for those of childbearing potential. The total duration for primary outcome assessment is 16 weeks, with safety and compliance monitored throughout.

Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)