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

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.