A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
研究概览
简要总结
The purpose of this study is to determine if complex lymphedema therapy is effective in decreasing disease severity and improving quality of life in patients with post thrombotic syndrome.
详细描述
Post thrombotic syndrome (PTS) has a spectrum of disease manifestations ranging from minor skin discoloration to severe skin changes and venous ulcerations. Pain is often a prominent symptoms and PTS impairs patient quality of life. Prevention of PTS using compression stockings has been emphasized. There is a paucity of validated, effective treatments for PTS once the condition develops.
While the pathophysiology of PTS is incompletely understood, chronic venous hypertension and insufficiency may increase the workload of the lymphatic system and result in over-capacitance with secondary damage and eventual lymphatic insufficiency. In selected patients with PTS, we have noted a symptomatic improvement in patients who receive lymphedema therapy to the limb.
Complex lymphedema therapy (CLT) is a noninvasive treatment that includes four key components: meticulous skin care, manual lymph drainage, compression therapy, exercises and patient education for home management and continuation of the treatment. These techniques are designed to enhance lymph flow through intact cutaneous lymphatics and reduce swelling and restore function in the affected limb.
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
- Single (Outcomes Assessor)
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.
- •Diagnosis of post thrombotic syndrome.
- •Median life expectancy of greater than 2 years.
- •Previous history of lower extremity deep venous thrombosis.
排除标准
- •Acute venous thrombosis of the lower extremity within the last 180 days.
- •Unable to participate in lymphedema therapy due to monetary, physical or transportation limitations.
- •Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women and women in their first post-partum month.
结局指标
主要结局
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
时间窗: 1 and 3 months
To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome
时间窗: 1 and 3 months
次要结局
- To assess side effects of lymphedema therapy when administered to patients with PTS(1 and 3 months)
- To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome(1 and 3 months)
研究者
Chris Holmes
Associate Professor of Medicine
University of Vermont