Compression Treatment of Superficial Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- pain assessed by VAS (cm)
研究概览
简要总结
Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.
This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.
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
- •patients with superficial vein thrombosis of the leg,
- •thrombus extent of at least 5 cm confirmed by duplex sonography,
- •clinical signs of inflammation (pain, erythema)
排除标准
- •superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
- •concomitant deep vein thrombosis,
- •thrombophilia,
- •active malignoma,
- •immobility,
- •peripheral arterial occlusive disease,
- •superficial vein thrombosis after sclerotherapy
- •incision and clot expression
- •excessive leg configuration not covered by ready made compression stockings
结局指标
主要结局
pain assessed by VAS (cm)
时间窗: at baseline, week 1, week 2, week 3
change from baseline to week 3 at weekly intervals
次要结局
- amount of analgetics (number of pills)(week 1, week 2, week 3)
- duplex-sonographic confirmation of deep vein thrombosis(at baseline and at week 3)
- skin erythema (cm2)(at baseline, week 1, week 2, week 3)
- quality of life (SF-36)(at baseline and at week 3)
- löwenberg test (mm Hg)(at baseline, week 1, week 2, week 3)
- duplex-sonographic change in thrombus length (cm)(at baseline, week 1, week 2, week 3)
研究者
Kornelia Boehler
MD
Medical University of Vienna