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

NCT06852976 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RPT-1228-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• Drug related treatment emergent adverse events

  Incidence (severity and causality) of any drug related local and systemic treatment emergent adverse events （TEAE） for 12 weeks during the study treatment.

  1-12 weeks

• Complete Healing and Time to closure for targeted diabetic foot ulcer

  The proportion of subjects with complete healing of the target ulcer area after 12 weeks of treatment

  1-12 weeks

Secondary Outcomes (1)

• Ulcer area reduced by 50%

  12 weeks

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Standard of Care for Diabetic Foot Ulcer

Other: Standard of Care Alone

Treatment Arm

EXPERIMENTAL

MDI-1228-mesylate Gel plus Standard of Care

Drug: 0.75% MDI-1228_mesylate gel plus Standard of Care

Interventions

0.75% MDI-1228_mesylate gel plus Standard of Care DRUG

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

Also known as: MDI-1228

Treatment Arm

Standard of Care Alone OTHER

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

Also known as: Standard of Care

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Site 001

Durham, North Carolina, 27703, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Amanda Fu, M.D.,MBA

CONTACT

3910204908; amanda.fu@d2vclinical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: March 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)