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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 12, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Diabetic Foot Ulcer
Interventions
DRUG

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.

OTHER

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.

Trial Locations (1)

27703

RECRUITING

Site 001, Durham

All Listed Sponsors
lead

Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

INDUSTRY