NCT03110796Unknown不适用
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomized, Controlled, Double-blind, European Multicentre Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- % of Wound Area Regression (WAR), as a measure of efficacy
研究概览
简要总结
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
详细描述
A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years old who has provided his/her written informed consent
- •Patient with Type 1 or Type 2 diabetes mellitus with glycated haemoglobin (HbA1c) level ≤ 10%
- •Inpatient or outpatient who can be monitored by the same investigating team throughout the entire study
- •Patient who agrees to wear an off-loading system during the trial
- •Diagnosis of peripheral neuropathy
- •Patient with an adequate arterial perfusion of the affected limb, confirmed by ABPI and Toe Blood Pressure assessment
- •DFU Grade 1-A or 2-A or 1-C or 2-C as defined by the University of Texas Diabetic Wound Classification System
- •Target DFU surface area between 1 cm² to 10 cm², after debridement
- •DFU present since less than 24 months
排除标准
- •A. Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control B. Patient who participated in another clinical trial in the previous month or who will take part in another clinical trial during the 12 weeks following the inclusion C. Patient with severe renal impairment D. Patient who has presented, during the 3 months before inclusion, an acute ischemic event (acute myocardial infarction or stroke) E. Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant F. Patient treated for a chronic disease requiring high doses of systemic corticosteroids on a daily basis (≥ 40 mg prednisolone) G. Patient with infection which is not controlled by a suitable antibiotic treatment H. Patient with any known allergy or reported adverse reaction to the trial device
结局指标
主要结局
% of Wound Area Regression (WAR), as a measure of efficacy
时间窗: 12 weeks
Efficacy of dressings with LU3103209 versus dressing without LU3103209
次要结局
未报告次要终点
研究者
研究点 (8)
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