Determination of Duration of Wearing Compression Hosiery Necessary to Reduce Subjective Symptoms of Chronic Venous Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS)
研究概览
简要总结
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease
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
- None
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
- •Symptomatic chronic venous disease
- •C0-C4 according to CEAP-classification
排除标准
- •C5-C6 according to CEAP-classification
- •Intolerance to compression socks
- •Patient's unwillingness to use compression socks
- •Inability to use compression socks
研究组 & 干预措施
Compression regimen 6-8 hours per day 4 weeks
40 participants. A physical examination and duplex ultrasound of the veins of the lower extremities are performed. It is suggested to wear the compression socks 6-8 hours a day for 4 weeks
干预措施: Compression socks (Device)
Compression regimen 10-12 hours per day 4 weeks
40 participants. An physical examination and duplex ultrasound of the veins of the lower extremities are performed. It is suggested to wear the compression socks 10-12 hours a day for 4 weeks
干预措施: Compression socks (Device)
结局指标
主要结局
Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS)
时间窗: Day 0, Day 7, Day 14, Day 21, Day 28
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no discomfort"/"no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)
时间窗: Day 0, Day 28
There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100.
次要结局
未报告次要终点