Natchez

The trial investigates 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 study is conducted across multiple medical centers and aims to evaluate wound healing outcomes and pain relief in patients with chronic diabetic foot ulcers. The study includes adult participants with diabetes mellitus who have ulcers that meet specific criteria. Participants are randomly assigned to receive either standard care alone or standard care plus NeoThelium FT, a wound covering made from human placental tissue. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to the NeoThelium FT treatment arm, receiving weekly applications for up to 12 visits. All participants undergo a two-week screening before randomization. During the study, participants have regular assessments including wound measurements and pain evaluations at specific intervals over 12 weeks. Researchers monitor the percentage of ulcers achieving full closure, wound area reduction, time to closure, and pain levels. The trial supports gathering data for insurance reimbursement decisions and tracks participants through follow-up visits according to the study schedule.

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.