Phase II Study of Topical BB-101 for Treating Diabetic Lower Leg and Foot Ulcers

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a topical medication called BB-101 for treating diabetic foot and lower leg ulcers. This phase II clinical trial is randomized, double-blinded, vehicle-controlled, and parallel in design. The study includes adults with diabetes who have chronic ulcers that have not healed despite standard care, aiming to provide new treatment options for these persistent wounds. Participants will be randomly assigned to one of three groups high dose BB-101, low dose BB-101, or a placebo. Each group will apply the assigned topical solution once daily to their target ulcer on the lower leg or foot for four consecutive weeks. All participants will continue to receive standard ulcer care throughout the study. The study is conducted at multiple locations and may expand to additional sites if needed. During the trial, participants will attend regular visits for assessments including measuring ulcer size and healing progress. Researchers will evaluate the efficacy of BB-101 after four weeks and monitor safety for six weeks. Participants will also undergo laboratory tests, physical exams, and other evaluations to ensure their health and track treatment effects. The total study duration and follow-up will cover these assessment periods to observe outcomes comprehensively.

BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers