Franklinton

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.