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Phase 2a Study of MDI-1228-mesylate Gel for Diabetic Foot Ulcers

This study is testing a new gel called MDI-1228-mesylate for people with diabetic foot ulcers. It compares the gel plus standard care (like wound cleaning) to standard care alone. The goal is to see if MDI-1228-mesylate gel helps ulcers heal completely and how quickly they close over 12 weeks. You might be able to join if you are 18-75 years old and have a diabetic foot ulcer. The study aims to enroll about 60 people. The current status of recruitment is unclear.

Study design
This is an open-label, randomized, controlled Phase 2a study. Approximately 60 participants will be randomly assigned to receive either MDI-1228-mesylate gel plus standard care or standard care alone.
What's involved
You would participate for up to 18 weeks, including a screening period, 12 weeks of treatment, and 4 weeks of follow-up. You would receive MDI-1228-mesylate gel twice daily if in that group.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 weeks after the 12-week treatment period, with an end-of-study visit at day 112.

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NCT06852976

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
~60 participants
Updated 2025-03-07 on ClinicalTrials.gov
What's tested:0.75% MDI-1228_mesylate gel plus Standard of CareStandard of Care Alone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Drug related treatment emergent adverse events
Measured over 1-12 weeks
+1 more outcome measured

Conditions

Diabetic Foot Ulcer

Explore related trials

Diabetic foot ulcer

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

Amanda Fu, M.D.,MBA
[email protected]
3910204908
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

What this trial measures

  • Drug related treatment emergent adverse events1-12 weeks

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

  • Complete Healing and Time to closure for targeted diabetic foot ulcer1-12 weeks

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