EUCTR2020-001365-36-SE进行中（未招募）1 期
A randomized double-blind clinical trial comparing Hypochlorous Acid and Polyhexamethylene biguanide in treating diabetic foot ulcers - Dakin´s - Diabetes
-hospital Group/Västra Götalandsregionen0 个研究点目标入组 202 人开始时间: 2020年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be included the subject must meet the following criteria:
- •Written and verbal informed consent given before trial-related activities
- •Diabetes type 1, type 2 or diabetes due to pancreatitis
- •Foot ulcer = 10 days
- •Ulcer surface area = 9 mm2
- •Age 18 years old or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 152
排除标准
- •Under 18 years old, serious infection (temp <36 or >38, heartrate >90 beats/minute, resp rate >20/min, LPK >12X10?9), condition needing intensive care and dialysis, treatment with immunotherapy and/or corticosteroids = 50 mg/day, event of myocardial infarction or stroke during the last 4 weeks, debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks
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