NCT02675335撤回3 期
Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
Wolfgang-Michael Franz0 个研究点开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- mean ulcer size after a treatment period of 12 weeks
研究概览
简要总结
The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm
- •stable size of the foot ulcer for at least 2 weeks
- •HbA1c <= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones
排除标准
- •local purulent signs of Inflammation at ulcer site
- •planned interventional or surgical therapy of a macro vessel disease of the lower limb
- •glomerular filtration rate <30ml/min
- •liver cirrhosis CHILD B or C
- •pregnancy, lactation
- •allergy against Sitagliptin
- •ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors
研究组 & 干预措施
Sitagliptin
Active Comparator
Sitagliptin tablets, 100mg per day, 12 weeks treatment
干预措施: Sitagliptin (Drug)
Placebo
Placebo Comparator
Placebo tablets, 1 tablet per day, 12 weeks treatment
干预措施: Placebo (Drug)
结局指标
主要结局
mean ulcer size after a treatment period of 12 weeks
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Wolfgang-Michael Franz
Professor
Medical University Innsbruck
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