Study of Porcine Placental Extracellular Matrix Plus Standard Care Compared to Standard Care Alone for Treating Hard-to-Heal Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of porcine placental extracellular matrix PPECM combined with standard care compared to standard care alone in helping hard-to-heal venous leg ulcers close. This multicenter, randomized, observer-blinded trial focuses on adults with venous leg ulcers that have not improved significantly with prior treatment. The study aims to determine if adding PPECM can improve healing outcomes over 12 weeks. Participants are randomly assigned to one of two groups one receiving standard care alone, which includes compression therapy, debridement, reducing bacterial burden, and maintaining moisture balance the other receiving weekly applications of the InnovaMatrix AC device a porcine placental extracellular matrix product alongside the same standard care. The treatment phase lasts 12 weeks, followed by long-term follow-up assessments at 3, 6, 9, and 12 months after wound closure or completion of treatment to evaluate durability of healing. During the study, participants attend weekly visits for treatment application and monitoring. Researchers assess outcomes such as complete ulcer closure, time to closure, percent reduction in ulcer area, and quality of life at multiple time points. Safety and efficacy are closely monitored through clinical evaluations and vascular assessments. The total participation duration includes the 12-week treatment period plus up to one year of follow-up for long-term results.

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone