Evaluating a new gel treatment for diabetic foot ulcers

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

This study is testing a new gel treatment for diabetic foot ulcers to see if it helps heal the wounds better than the usual care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: baricitinib, ruxolitinib
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06852976 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of MDI-1228-mesylate Gel in comparison to standard care for patients with diabetic foot ulcers. Approximately sixty participants will be enrolled and randomized to receive either the gel plus standard care or standard care alone. The primary outcome will be the complete healing rate of the target ulcer after 12 weeks, along with the reduction in ulcer area. The study will include a screening period, treatment phase, and follow-up to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with diabetic foot ulcers that have persisted for at least 12 weeks.

Not a fit: Patients with systemic infections or those with ulcers larger than 25cm2 will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers.

How similar studies have performed: Other studies have shown promise in treating diabetic foot ulcers with novel topical agents, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Male or female 18-75 years;
3. 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:

1. Allergy to the main components or excipients of MDI-1228\_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
2. Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
3. The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
4. Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.

Where this trial is running

Durham, North Carolina

• Site 001 — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Amanda Fu, M.D.,MBA

Conditions Diabetic Foot Ulcer