Spicewood

Researchers are evaluating the effects of a cellular, acellular, matrix-like product called Amnio-Maxx Dual Layer Amnion Patch compared to the standard care alone on healing chronic diabetic foot ulcers (DFUs). This Phase 4 study focuses on patients with nonhealing DFUs, aiming to assess how well the Amnio-Maxx patch helps close these ulcers and reduce their size over 12 weeks. Participants will receive either the Amnio-Maxx patch plus standard care or standard care alone. Standard care includes cleansing, debridement, wound documentation, and off-loading the affected foot. The study involves a screening period followed by randomization to one of the treatment groups, with treatments applied during visits. The index ulcer must be offloaded and have a clean base before treatment. During the study, participants' ulcers will be monitored for complete closure and percentage area reduction at 12 weeks. Researchers will conduct wound assessments, document healing progress, and ensure adherence to offloading. Safety and effectiveness will be tracked throughout, with participants required to follow protocol guidelines and attend scheduled visits during the study period.