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RECRUITING
NCT06852976
PHASE2

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.

View on ClinicalTrials.gov

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

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.

Locations (1)

Site 001

Durham, North Carolina, United States