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 (DFU)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: Standard of Care Alone; Drug: 0.75% MDI-1228_mesylate gel plus Standard of Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amanda Fu, M.D.,MBA; Phone Number: 3910204908; Email: amanda.fu@d2vclinical.com

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Recruiting
      • Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Standard of Care for Diabetic Foot Ulcer	Other: 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.; Other Names: Standard of Care
Experimental: Treatment Arm; MDI-1228-mesylate Gel plus Standard of Care	Drug: 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.; Other Names: MDI-1228

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer area reduced by 50%	The proportion of subjects whose ulcer area was reduced by 50% after 12 weeks of treatment. [The ulcer area will be calculated using a photograph of the ulcer area and PI assessment.]	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory - Rate and quality of granulation tissues	The rate of granulation and quality of granulation tissues on the target ulcer surface at each site.	1-12 weeks
Exploratory - Compare healing between controlled vs uncontrolled Diabetes Mellitus	Comparison healing between controlled HbA1C<6.5% vs uncontrolled DM ≥6.5%.	1-12 weeks
Exploratory - Comparing healing between controlled fasting glucose and uncontrolled	Comparison healing between controlled fasting glucose <120 mg/dL vs uncontrolled fasting glucose ≥120 mg/dL	1-12 weeks
Exploratory - Time to healing between ulcers greater than 1 year old versus less than 1 year old	Time to healing between ulcers >1 year old vs < 1 year old	1-12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: RPT-1228-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No