MDI-1228 Mesylate Gel for Foot Ulcer
(DFU Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Must not be taking: JAK inhibitors

Disqualifiers: Cancerous ulcers, Lupus, Rheumatoid arthritis, others

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

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 am between 18 and 75 years old.

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

+5 more

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

+16 more

Trial 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)

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

MDI-1228-mesylate Gel plus Standard of Care

Group II: Control ArmActive Control1 Intervention

Standard of Care for Diabetic Foot Ulcer