Denham Springs

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.

Researchers are evaluating the healing of diabetic foot ulcers by comparing the usual standard of care (SOC) treatment alone with SOC combined with Omeza4 Complete Matrix (OCM). The study seeks to determine if adding OCM helps increase the chances of complete wound closure within 12 weeks. This trial is open-label and conducted at multiple medical centers, involving adult patients with diabetic foot ulcers that meet specific healing and size criteria. Participants will be randomly assigned to receive either SOC alone or SOC plus OCM. SOC includes surgical sharp debridement, offloading using methods like total contact casting or fixed ankle-walker, and maintaining proper moisture balance. Patients in the SOC group who do not achieve complete wound closure by about 84 days may switch to the SOC plus OCM group for up to 12 weekly treatments while continuing follow-up visits. This crossover design allows additional assessment of OCM's effects after initial treatment. During the study, participants will undergo regular treatment visits and follow-ups, with wound healing closely monitored. Researchers will measure the primary outcome of complete wound closure within 1 to 12 weeks. Assessments include wound measurements, infection control, circulation checks, and adherence to offloading therapy. Safety and treatment effectiveness data will be collected to support future insurance reimbursement decisions and provide detailed information on OCM's role in diabetic foot ulcer care.