Natchez

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label, randomized controlled crossover trial involves patients with chronic diabetic foot ulcers and aims to assess wound healing within 12 weeks. The study is conducted across multiple medical centers and includes a crossover option for patients not healed after initial treatment with standard care alone. Participants are randomly assigned to either standard care, which includes wound cleansing, debridement, moisture-balancing dressings, and offloading, or to standard care plus weekly applications of NeoThelium FT, a dual-layer membrane derived from donated human placental tissue. Those in the standard care group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT weekly for up to 12 visits while continuing scheduled follow-up. Before randomization, all participants undergo a two-week screening phase. During the study, researchers will monitor wound closure rates, time to closure, wound area reduction, and pain. Assessments include measuring wound healing progress and ensuring ulcers remain free of infection. The study supports data collection for insurance reimbursement decisions and includes safety monitoring throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial takes place at multiple medical centers and is open label, meaning both researchers and participants know the treatment being given. The study aims to support insurance decisions by gathering data on wound healing and pain reduction, focusing on wounds that have not sufficiently healed within 14 days prior to screening. Participants will be randomly assigned to either receive standard care alone—which includes wound cleansing, sharp debridement, moisture-balancing dressings, and offloading therapy—or standard care plus weekly applications of NeoThelium FT, a dual-layer wound covering made from human placental tissue. After about 84 days, those in the standard care group whose wounds have not fully closed may switch to the NeoThelium FT treatment for up to 12 weekly applications, continuing follow-up as scheduled. Participants will undergo a two-week screening before randomization. Throughout the study, researchers will monitor wound closure rates over 12 weeks, wound size reduction, and pain levels. Assessments will include wound measurements and evaluations for infection or complications. Safety and adherence to treatment protocols will be closely observed during the study period.