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Researchers are evaluating the effectiveness of NeoThelium FT combined with standard wound care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial involves patients with chronic open wounds that have not healed sufficiently, aiming to assess wound closure rates within 12 weeks. The study is open label and conducted at multiple medical centers, supporting post-marketing evaluation and insurance reimbursement decisions. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT with standard care for up to 12 additional weekly treatments. Standard care includes wound cleansing, debridement, moisture-balancing dressings, and offloading. Before randomization, participants undergo a two-week screening phase. Throughout the study, wound healing progress and pain levels are regularly assessed, including wound area measurements and pain evaluations at specified time points. The primary measurement is the rate of complete wound closure within 12 weeks, with secondary outcomes assessing wound size reduction and pain. The study duration extends through treatment and follow-up visits, concluding by October 2026.

Researchers are evaluating the use of NeoThelium FT Amnion Skin Graft in managing diabetic foot ulcers. This prospective case series aims to assess the safety and effectiveness of this treatment in patients with diabetes who have foot ulcers. The study is open label and conducted across multiple medical centers, focusing on gathering evidence to support insurance coverage decisions. Participants will receive standard care combined with weekly applications of NeoThelium FT, which is a dehydrated membrane made from donated human placental tissue. The treatment includes wound cleansing, sharp debridement, application of the graft, dressing to maintain moisture balance, and offloading to protect the wound. Patients continue follow-up visits according to the original schedule, with close monitoring throughout the study. During the trial, researchers will track wound healing progress, including the time to complete wound closure within 1 to 12 weeks. They will also measure changes in wound area, hemoglobin A1c levels, and follow-up wound closure two weeks after treatment. Safety and treatment effectiveness are monitored with regular assessments, and participation may last up to 12 weeks or more depending on healing progress.