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
Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
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.
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 scr…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures; 2. Male or female 18-75 years; 3. Meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics: * 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 b…
Interventions
- Drug0.75% MDI-1228_mesylate gel plus Standard of Care
Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.
- OtherStandard 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.
Location
- Site 001Durham, North Carolina