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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

NCT06852976 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-07

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852976 on ClinicalTrials.gov