MDI-1228 Mesylate Gel for Foot Ulcer

(DFU Trial)

Recruiting at 1 trial location

Overseen By Amanda Fu, M.D.,MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: JAK inhibitors

Disqualifiers: Cancerous ulcers, Lupus, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should have been on standard care for at least 4 weeks before joining, which might imply continuing some treatments.

What is the purpose of this trial?

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 Criteria

This study is for individuals with chronic diabetic foot ulcers. Participants should have a specific type of long-lasting wound on their feet due to diabetes and are seeking additional treatment options beyond standard care.

Inclusion Criteria

I have a diabetic ulcer that fits certain criteria.

Subjects of child-bearing potential and their sexual partners do not plan to become pregnant within 3 months after the last dose of the investigational drug and must use effective contraception

I am willing to follow the study's schedule and procedures.

Exclusion Criteria

I have cancerous ulcers or a connective tissue disease.

I have a serious infection or possible cancer at my ulcer site.

Abnormal blood counts or levels in screening period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive MDI-1228-mesylate Gel plus standard of care or standard of care alone for diabetic foot ulcers

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• MDI-1228 Mesylate Gel

Trial Overview The trial is testing the effectiveness of a gel called MDI-1228 Mesylate, used alongside regular wound care, against using just the usual wound treatments alone. The main goal is to see if the gel helps heal foot ulcers better over 12 weeks.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

MDI-1228-mesylate Gel plus Standard of Care

Group II: Control Arm Active Control 1 Intervention

Standard of Care for Diabetic Foot Ulcer

Who Is Running the Clinical Trial?

Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

Lead Sponsor

Trials

1

Recruited

60+