North Port

Researchers are evaluating the effectiveness of using porcine placental extracellular matrix (PPECM) together with the standard care approach compared to standard care alone in healing hard-to-treat venous leg ulcers. This study is a multicenter, observer-blinded, randomized controlled trial designed to assess wound closure in patients with venous leg ulcers that have not responded well to previous treatments. Participants will be divided into groups where one group receives weekly applications of InnovaMatrix4 AC, a device delivering PPECM, along with standard wound care, while the other group receives only standard care. The treatment period spans 12 weeks, during which the study monitors the healing progress of the ulcers. Throughout the study, participants will attend weekly visits to receive treatment and assessments. Researchers will measure wound healing progress, specifically looking for complete closure of the ulcers within 12 weeks. Safety and tolerability will also be monitored during the study period to evaluate the treatments' effects on hard-to-heal venous leg ulcers.