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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment effect of MDI-1228-mesylate Gel compared with standard care alone in people with diabetic foot ulcers. The study aims to measure the complete healing rate after 12 weeks of treatment and the proportion of patients whose ulcer size is reduced by half. This Phase 2a trial plans to enroll about sixty adults aged 18 to 75 years with specific diabetic ulcers that have lasted at least 12 weeks. Participants will be randomly assigned in a 2:1 ratio to either receive the study gel plus standard care or standard care alone. The gel will be applied twice daily for 12 weeks. Standard care includes wound cleaning, debridement, and other treatments as determined by healthcare providers. All ulcers will be treated, but only the largest ulcer will be the focus of measurement. The trial includes up to a 14-day screening period, 12 weeks of treatment, and a 4-week follow-up. During the study, participants will have their ulcers regularly monitored and photographed by designated staff to ensure consistency. Researchers will assess healing progress, time to ulcer closure, and any treatment-related side effects. Participants will attend visits at the end of treatment and at follow-up to evaluate outcomes, with the total study lasting up to 18 weeks.
CONDITIONS
Brief 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 provide signed informed consent
- Male or female aged 18 to 75 years
- Diagnosed with diabetic ulcer with at least one target ulcer located on the foot or below the knee
- Target ulcer is Wagner grade 2, without systemic infection
- Target ulcer is the largest ulcer and less than 25 cm² in size
- Target ulcer has persisted for at least 12 weeks and been treated with standard care for at least 4 weeks
- Minimum 3 cm margin between target ulcer and any other ulcers on the foot post-debridement
You will not qualify if you...
- Allergy to MDI-1228-mesylate gel components or JAK inhibitors (tofacitinib, baricitinib, ruxolitinib)
- Skin ulcers or chronic wounds caused by electroshock, chemicals, or radioactive material
- Target ulcer has reduced in size by 30% or more in last 4 weeks under standard treatment
- Presence of cancerous ulcers or connective tissue diseases such as lupus, rheumatoid arthritis, scleroderma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive either MDI-1228-mesylate gel plus standard of care or standard of care alone for diabetic foot ulcers.
Regular visits during treatment period (visit schedule as per protocol)
Duration - Up to 4 weeks
Participants are monitored after treatment ends to assess healing and safety outcomes.
1 visit (in-person)
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
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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