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This research aims to evaluate how well NeoThelium FT Amnion Skin Graft works and how safe it is for treating chronic pressure ulcers. The study will take place at multiple medical centers using an open-label design, meaning both patients and researchers will know which treatment is being given. It is a post-marketing study intended to gather information on the treatments effectiveness and to support insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, which is a dehydrated wound covering made from donated human placental tissue with amnion and chorion layers. Treatment includes wound cleansing, sharp debridement, applying NeoThelium FT, dressing for moisture balance, and offloading to reduce pressure. Patients will continue follow-ups according to the original schedule. During the study, participants will be assessed for wound healing progress including complete wound closure within 1 to 16 weeks, percent area reduction, wound closure at 2 weeks, and the number of grafts used. Researchers will monitor safety and treatment adherence throughout the study period, which is expected to last up to 16 weeks. This helps understand the treatments impact on chronic pressure ulcers over time.

Age: 18Years +All GendersPhase Not Applicable
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