RecruitingPhase 2NCT06852976

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

Sponsor

Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

Enrollment

60 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

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 ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

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 Criteria4

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.

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Interventions

DRUG0.75% MDI-1228_mesylate gel plus Standard of Care

Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.

OTHERStandard of Care Alone

Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.