A Multicenter Trial Comparing Multiple Human Placental Skin Substitutes Plus Standard Care to Standard Care Alone for Treating Hard-to-Heal Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of four different dehydrated complete human placental membrane products, known as Cellular, Acellular, Matrix-like Products CAMPs, combined with standard care versus standard care alone in healing hard-to-heal diabetic foot ulcers. This study uses a unique modified platform trial design to compare multiple skin substitute products within one clinical trial. The goal is to achieve complete wound closure of diabetic foot ulcers over a 12-week period. Participants will be randomly assigned to receive one of the four placental membrane productsRevita, Relese, Cogenex, or Enverseeach applied weekly alongside standard care, or to receive standard care alone. Standard care includes cleaning, debridement, moisture balance for the ulcer, and offloading to reduce pressure on the foot. Treatments continue weekly until the ulcer heals or up to 12 weeks, whichever comes first. During the study, participants will attend weekly visits for treatments and assessments. Researchers will monitor the percentage of ulcers that fully close within 12 weeks, the time it takes for ulcers to close, reduction in ulcer size, pain changes, adverse events, and improvements in quality of life. The study includes detailed evaluations such as imaging of ulcers and vascular assessments to ensure adequate blood flow. Participants safety and wound healing progress will be closely followed throughout the trial and up to 14 weeks.

Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs