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

NCT ID: NCT06852976

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

The study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. All subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus standard of care or standard of care alone.

All subjects who meet inclusion/exclusion criteria will have all ulcers treated; however, only one ulcer, the largest, will be selected as the target ulcer.

Before performing any study procedures, all potential subjects will sign an informed consent form (ICF).

The total study duration is anticipated to be up to 18 weeks, including:

• Up to a 14-day screening period
• Up to 12 weeks study treatment
• Up to 4 weeks of follow-up
• End-of-treatment visit will be performed on the last day of treatment (D84)
• End-of-Study visit will be performed at the follow-up visit (D112)

Wound photography should be dedicated to one study site personnel to control variance.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

Standard of Care for Diabetic Foot Ulcer

Group Type: ACTIVE_COMPARATOR

Standard of Care Alone

Intervention Type: OTHER

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

Treatment Arm

MDI-1228-mesylate Gel plus Standard of Care

Group Type: EXPERIMENTAL

0.75% MDI-1228_mesylate gel plus Standard of Care

Intervention Type: DRUG

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

Interventions

0.75% MDI-1228_mesylate gel plus Standard of Care

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

Intervention Type: DRUG

Standard 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.

Intervention Type: OTHER

Other Intervention Names

MDI-1228; Standard of Care

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 001

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda Fu, M.D.,MBA

Role: CONTACT

amanda.fu@d2vclinical.com

3910204908

Other Identifiers

RPT-1228-101

Identifier Type: -

Identifier Source: org_study_id