MDI-1228 Mesylate Gel for Foot Ulcer
(DFU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gel treatment called MDI-1228 Mesylate Gel for individuals with diabetic foot ulcers. The goal is to determine if the gel, when combined with regular care, can completely heal ulcers in 12 weeks or reduce their size by half. Participants will receive either the gel with standard care or standard care alone. The trial seeks individuals who have had a diabetic foot ulcer for at least 12 weeks that has not significantly improved with regular treatment. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that MDI-1228 Mesylate Gel is likely to be safe for humans?
Research has shown that MDI-1228 Mesylate Gel is usually well-tolerated. In earlier studies, side effects were mostly mild, and most patients did not experience major negative reactions. This suggests the gel is safe for people with diabetic foot ulcers. However, as the treatment remains under study, new safety information may emerge.12345
Why do researchers think this study treatment might be promising?
Unlike the standard care for diabetic foot ulcers, which typically involves wound cleaning, dressing, and possibly antibiotics or surgery, MDI-1228 Mesylate Gel offers a novel approach by combining a new active ingredient with existing treatments. This gel is designed to enhance healing by directly targeting the ulcer site, potentially speeding up recovery. Researchers are excited about this treatment because it could offer a more effective and faster-healing option for patients, addressing a significant need in diabetic foot ulcer care.
What evidence suggests that MDI-1228 Mesylate Gel might be an effective treatment for diabetic foot ulcers?
Research has shown that MDI-1228 Mesylate Gel, which participants in this trial may receive, may help treat diabetic foot ulcers. Studies have found that it can improve the healing rate of these ulcers compared to standard care alone. Specifically, in previous patients, the size of the ulcer was reduced by 50% after 12 weeks of using the gel. This gel accelerates the body's natural healing process, potentially closing stubborn wounds faster. While more information is needed, early results suggest MDI-1228 Mesylate Gel could be a promising option for people with diabetic foot ulcers.24567
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MDI-1228-mesylate Gel plus standard of care or standard of care alone for diabetic foot ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MDI-1228 Mesylate Gel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Lead Sponsor