A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Completely healing time of the participants'target ulcer during the treatment period.
研究概览
简要总结
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
详细描述
Groups:
Diabetic ulcers, saxagliptin + Regular treatment.
Diabetic ulcers, placebo + Regular treatment.
Time Point:
Initial treatment;
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, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
- •Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)
- •The subject agrees to comply with study protocol requirements and all follow up visit requirements.
排除标准
- •Uncontrolled diabetes
- •Ulcer infection
- •Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions
研究组 & 干预措施
saxagliptin
saxagliptin & Regular treatment:
saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd
干预措施: saxagliptin (Drug)
placebo
placebo & Regular treatment:
placebo, dose: 5mg, po, qd
干预措施: placebo (Drug)
结局指标
主要结局
Completely healing time of the participants'target ulcer during the treatment period.
时间窗: 16 weeks
Complete ulcer closure is defined as 100% skin re-epithelialization
次要结局
- Proportion of participants with complete healing during the treatment period.(16 weeks)
研究者
Long Min,MD
Principal Investigator
Xinqiao Hospital of Chongqing