Study Comparing Human Placental Membrane Products Plus Standard Care to Standard Care Alone for Treating Nonhealing Diabetic Foot and Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of multiple human placental membrane products, called CAMPs, combined with Standard of Care SOC versus SOC alone in treating nonhealing diabetic foot ulcers DFUs and venous leg ulcers VLUs. This multicenter, prospective, randomized controlled trial uses a modified platform design to compare different CAMP products, including AMSingle and AMDouble, in promoting ulcer closure over 12 weeks. Participants will receive weekly treatments depending on their assigned group. The Standard of Care involves cleaning, debridement, moisture balance, and offloading or compression as appropriate. Those in CAMP groups will receive weekly applications of either AMSingle a single layer human amniotic membrane allograft or AMDouble a double layer allograft in addition to Standard of Care. Treatment continues until the ulcer closes or up to 12 weeks. During the study, participants will attend weekly visits for treatment and evaluation. Researchers will assess ulcer closure rates, time to closure, percent area reduction, pain changes, adverse events, and quality of life improvements over 12 weeks. The study monitors participants closely to measure healing progress and safety of the treatments throughout the trial duration.

Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs