NCT04574375已完成不适用
A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease
Servier Affaires Médicales1 个研究点 分布在 1 个国家目标入组 6,419 人开始时间: 2020年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,419
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Patient consulting spontaneously or referred for symptomatic venous disorders
- •Diagnosis of chronic venous disease according to investigator's judgment
排除标准
- •Presence of known severe systemic disease likely to interfere with the study evaluation
- •Patients with lower limb arterial disease
- •Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema
- •Patient consulting for an emergency not related to venous disease
- •Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery
- •Procedure or surgery for venous disease planned during the study
- •Pregnant or breastfeeding woman
结局指标
主要结局
Quality of Life
时间窗: Week 4
Measured by CIVIQ-14 questionnaire
Global improvement
时间窗: Week 4
Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.
Global leg symptoms severity
时间窗: week 4
Measured by visual analogue scale (VAS) and questioning with 4 points rate
Disease severity
时间窗: Week 4
Measured by VCSS (Venous Clinical Severity score)
次要结局
未报告次要终点
研究者
研究点 (1)
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