A Randomized,Double-Blind,Vehicle-controlled,Parallel,Phase II Study to Evaluate Efficacy and Safety of CSTC1 in Patient With Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Ulcer Closure During the Treatment Period
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
详细描述
This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU). In each study site, eligible patients were randomized in a 4:1 ratio to receive either one of the topical applications of CSTC1 or CSTC1 matched vehicle, topical application on target diabetic foot ulcer (DFU), 2 times daily.
The treatment duration for each subject was 12 weeks or up to confirmed complete ulcer closure, whichever comes first. That was, subjects would receive treatment for at most 12 weeks, which consists of 8 visits located at weeks 1, 2, 3, 4, 6, 8, 10, and 12. Subjects who achieved confirmed complete ulcer closure during the treatment period would be arranged for a 12 week post-treatment follow-up. Subjects failed to achieve complete ulcer closure at week-12 visit would be arranged for 4 weeks of safety follow-up. If confirmation of complete ulcer closure was reached at a week-14 visit, the subject would continue the post-treatment follow-up visit until week-24 visit. Otherwise, the subject would be arranged for safety follow-up until week-16 visit.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With either gender aged at least 20 years old;
- •With a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
- •The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner system;
- •The target ulcer should show "infection control" at investigator's discretion;
- •Subject should be free of any necrosis or infection in soft and bone tissue;
- •Subject has signed the written informed consent form
排除标准
- •With active osteomyelitis;
- •With target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit;
- •With poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/mm3, abnormal liver function (AST, ALT>3 x upper limit of normal range);
- •Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
- •Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
- •Receiving revascularization surgery performed <8 weeks before entry in the study;
- •With known or suspected hypersensitivity to any ingredients of study product and vehicle;
- •With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study;
- •Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
- •Enrollment in any investigational drug trial within 4 weeks before entering this study;
- •With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
研究组 & 干预措施
CSTC1
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
干预措施: CSTC1 (Drug)
CSTC1 Matched vehicle
Matched vehicle, topical, two times daily
干预措施: CSTC1 Matched vehicle (Drug)
结局指标
主要结局
Number of Participants With Complete Ulcer Closure During the Treatment Period
时间窗: Baseline to 14 weeks
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success.
次要结局
- The Ulcer Closure Time(24 weeks)
- The Accumulated Participant Counts With Complete Ulcer Closure(24 weeks)
- Percentage Change in Ulcer Size for Each Post-treatment Visit(baseline and 24 weeks)