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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-28
• Last updated: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study