Actively 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
Led by Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd. · Updated on 2025-03-07
60
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 aged 18 to 75 years
- Have a diabetic ulcer with at least one target ulcer located on the dorsal or plantar surface of the foot or below the knee
- Target ulcer is Wagner grade 2, located at or below the knee, without systemic infection
- Target ulcer is the largest ulcer and all ulcers are smaller than 25 cm2
- Target ulcers have persisted for at least 12 weeks prior to enrollment and have been treated with standard care for at least 4 weeks prior to enrollment
- There is at least a 3 cm margin between the target ulcer and any other ulcers on the same foot (after debridement)
You will not qualify if you...
- Allergy to main components or excipients of MDI-1228-mesylate gel, allergy to JAK inhibitors (tofacitinib, baricitinib, ruxolitinib), or allergic constitution
- Skin ulcers or chronic wounds caused by electroshock, chemicals, or radioactive material
- Target ulcer has reduced in size by 50% or more in the past 4 weeks under standard treatment
- Presence of cancerous ulcers or connective tissue diseases such as lupus erythematosus, rheumatoid arthritis, or scleroderma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Site 001
Durham, North Carolina, United States, 27703
Actively Recruiting
Research Team
A
Amanda Fu, M.D.,MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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