EUCTR2016-004143-36-SK进行中（未招募）1 期
Dose-response relationship study of S42909 on leg ulcer healing after oralrepeated administration in patients with active venous leg ulcer.A 10-week randomized, double-blind, placebo-controlled, prospective,international, multicentre, phase IIa study.
Ilkos Therapeutic Inc.0 个研究点目标入组 121 人开始时间: 2017年5月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
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
- •- Caucasian, men or women :
- •- Age = 18 years old.
- •- 18.5 kg/m2 = BMI = 45.0 kg/m2 (= Weight (kg) / height² (m²)).
- •Patients with chronic venous disease documented by imaging to
- •detect a venous disorder in the sub- and extra-fascial venous system.
- •The examination performed within 6 months before selection can be
- •- Patients with at least one active venous leg ulcer localised in the gaiter
- •area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less
- •than 2 years at selection and 3 cm away from other ulcers. Patients with
- •bilateral ulcerations or multiple ulcerations on one or both legs are
- •eligible for selection.
- •- Size of Reference Ulcer (defined as the largest ulcer in size that is
- •fitting the area selection criteria) should be = 5 cm2 and = 100 cm2
- •(measured by transparent sheet and confirmed with the digital 3D
- •imaging device).
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •- Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.
研究者
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