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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
Sponsor: Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Summary
The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-12
Completion Date
2025-12
Last Updated
2025-03-07
Healthy Volunteers
No
Conditions
Interventions
0.75% MDI-1228_mesylate gel plus Standard of Care
Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.
Standard of Care Alone
Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.
Locations (1)
Site 001
Durham, North Carolina, United States