Status:
RECRUITING
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
Lead Sponsor:
Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ulcer...
Detailed Description
The study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. All subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus sta...
Eligibility Criteria
Inclusion Criteria:
-
Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures;
-
Male or female 18-75 years;
-
Meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics:
- Located on dorsal or plantar surface of foot or below the knee.
- Wagner grade 2, ulcerated lesion at or below the knee, without systemic infection.
- The target ulcer should be the largest, and all each individual ulcers size should be less than 25cm2. All ulcers will be treated the same as the target ulcer.
- Target ulcers persisted for at least 12 weeks prior to enrollment and have been on standard of care for at least 4 weeks prior to enrollment.
- There is a minimum 3cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement).
Exclusion Criteria:
- Allergy to the main components or excipients of MDI-1228_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
- Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
- The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
- Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06852976
Start Date
March 12 2025
End Date
December 1 2025
Last Update
March 7 2025
Active Locations (1)
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1
Site 001
Durham, North Carolina, United States, 27703