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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Study ID
NCT06852976
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 0.75% MDI-1228_mesylate gel plus Standard of Care — DRUG
    Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.
  • Standard of Care Alone — OTHER
    Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.

Study Details

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 Dates

Start date
Mar 12, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm
    Standard of Care for Diabetic Foot Ulcer
  • Experimental: Treatment Arm
    MDI-1228-mesylate Gel plus Standard of Care

Primary Outcome Measure

Drug related treatment emergent adverse events [ Time Frame: 1-12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site 001DurhamNorth Carolina27703-

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By research site
Site 001· Durham, NC

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