Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Arm Volume
研究概览
简要总结
The purpose of this study is to determine how well different treatments for acquired lymphedema work.
The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
详细描述
This study will compare 5 non-invasive lymphedema treatments.
Patients will be assigned to either:
- A combination of arm exercises, arm elevation, and wearing of a compression garment every day
OR
- One of four possible pneumatic compression devices for just two hours every day.
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 (Investigator)
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 diagnosed with acquired lymphedema of the arm.
排除标准
- •Refusal of consent
- •Unlikely compliance with the research protocol
- •Acute upper extremity DVT
研究组 & 干预措施
Group B
Pneumatic Compression Device (B)
干预措施: E0650 PCD with non-sequential waveform (Device)
Group A
Exercise, Elevation, and Garment Compression
干预措施: Exercise, Elevation, and Compression Garment (Other)
Group C
Pneumatic Compression Device (C)
干预措施: E0651 PCD with sequential, non-gradient waveform (Device)
Group D
Pneumatic Compression Device (D)
干预措施: E0652 PCD with sequential, gradient waveform (Device)
Group E
Pneumatic Compression Device (E)
干预措施: E0652 PCD with peristaltic pulse waveform (Device)
结局指标
主要结局
Arm Volume
时间窗: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
次要结局
- Infection (cellulitis)(Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts)
- Quality of Life Survey(Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts)