Phase 2a Study Evaluating Safety and Effectiveness of MDI-1228-mesylate Gel Plus Standard Care Versus Standard Care Alone in Adults With Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the treatment effect of MDI-1228-mesylate Gel compared with standard care alone in people with diabetic foot ulcers. The study aims to measure the complete healing rate after 12 weeks of treatment and the proportion of patients whose ulcer size is reduced by half. This Phase 2a trial plans to enroll about sixty adults aged 18 to 75 years with specific diabetic ulcers that have lasted at least 12 weeks. Participants will be randomly assigned in a 21 ratio to either receive the study gel plus standard care or standard care alone. The gel will be applied twice daily for 12 weeks. Standard care includes wound cleaning, debridement, and other treatments as determined by healthcare providers. All ulcers will be treated, but only the largest ulcer will be the focus of measurement. The trial includes up to a 14-day screening period, 12 weeks of treatment, and a 4-week follow-up. During the study, participants will have their ulcers regularly monitored and photographed by designated staff to ensure consistency. Researchers will assess healing progress, time to ulcer closure, and any treatment-related side effects. Participants will attend visits at the end of treatment and at follow-up to evaluate outcomes, with the total study lasting up to 18 weeks.

A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers