Evaluation of Safety and Clinical Performance of Tropocells Autologous Platelet-rich Fibrin for Chronic Diabetic Foot Ulcers in Adults

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the Tropocells Autologous Platelet-rich Fibrin (PRF) system in treating mild to moderate neuroischemic diabetic chronic foot ulcers in adults aged 18 to 80 years with Type 1 or Type 2 Diabetes Mellitus. The study focuses on wound closure and safety outcomes in approximately 30 participants without a comparison group. The ulcers targeted are Grade 1 and 2, non-infected, and located below the ankle. The study begins with a 2-week run-in phase where participants receive standard wound care including nutritional supplements, wound cleansing, debridement, dressings, mild compression, and off-loading with a removable boot, attending weekly clinic visits. Participants who show less than 20% wound reduction during this phase may enter a 12-week active treatment phase, receiving weekly applications of the Tropocells Autologous PRF gel clot on the wound bed alongside standard care. After complete wound closure with two consecutive weekly assessments, participants enter a follow-up phase with evaluations at 1 and 3 months to monitor wound status. Participants will have wounds assessed weekly during treatment through photographs and measurements. Data collected includes wound area reduction and adverse events to evaluate safety. Follow-up visits after closure confirm if wounds remain closed. The study involves monitoring for safety issues throughout screening and treatment phases, with total participation lasting up to about 5 months including follow-up.

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.