A Randomized Study Comparing Multiple Cellular and Matrix-like Products Plus Standard Care to Standard Care Alone for Nonhealing Diabetic Foot and Venous Leg Ulcers

What this Trial Is About

The trial investigates the treatment of nonhealing diabetic foot ulcers DFU and venous leg ulcers VLU by comparing several cellular, acellular, and matrix-like products CAMPs combined with standard of care SOC against SOC alone. It aims to determine the difference in the proportion of patients achieving complete closure of these ulcers over 12 weeks using a modified dual platform design called Matriarch. The study may evaluate up to five CAMPs per wound type, with flexibility to include more as needed. Participants receive weekly treatments either with SOC alone or SOC plus one of several CAMPs. SOC includes cleaning, debridement, moisture balance, and offloading for DFUs, or compression for VLUs. CAMPs tested include various types of amniotic membrane allografts applied weekly alongside SOC, continuing until ulcer closure or a maximum of 13 weeks. The study has multiple arms representing different CAMP products and SOC for both DFUs and VLUs. Throughout the study, participants attend weekly visits where ulcer healing progress is assessed, including measurements of closure, time to closure, and area reduction. Pain levels and quality of life improvements are monitored alongside safety through adverse event tracking up to 14 weeks. The trial involves regular assessments to evaluate the effectiveness of treatments and patient well-being during the treatment period and follow-up.

Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs