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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Drug related treatment emergent adverse events
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Male or female 18-75 years;
- •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 be less than 25cm
- •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).
排除标准
- •Allergy to the main components or excipients of MDI-1228_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
- •Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
- •The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
- •Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.
研究组 & 干预措施
Control Arm
Standard of Care for Diabetic Foot Ulcer
干预措施: Standard of Care Alone (Other)
Treatment Arm
MDI-1228-mesylate Gel plus Standard of Care
干预措施: 0.75% MDI-1228_mesylate gel plus Standard of Care (Drug)
结局指标
主要结局
Drug related treatment emergent adverse events
时间窗: 1-12 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 ulcer
时间窗: 1-12 weeks
The proportion of subjects with complete healing of the target ulcer area after 12 weeks of treatment
次要结局
- Ulcer area reduced by 50%(12 weeks)