Study to Test Placental Membrane Dressings for Healing Diabetic Foot Ulcers in Adults Aged 45 to 85

What this Trial Is About

Researchers are evaluating the effectiveness of placental membrane dressings in speeding up the healing of diabetic foot ulcers. This randomized, open-label Phase 4 trial compares the healing process of patients treated with dehydrated placental membrane dressings to matched historical controls who received standard care. The study focuses on adults with diabetic foot ulcers that have not improved sufficiently with standard treatment. Participants in the study will receive the placental membrane dressing applied to their diabetic foot ulcer. The trial compares this treatment to historical control patients who received no intervention beyond standard care. The study includes a treatment period of 12 weeks during which wound closure and healing progress will be monitored. During the study, participants will have their wounds assessed regularly to measure wound closure, time to wound closure, and percent change in wound size over 12 weeks. Researchers will track these outcomes to evaluate the treatments impact. Participants must follow study instructions, attend all visits, and adhere to off-loading protocols to support healing. The total participation time matches the 12-week observation period.

Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing