Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.
详细描述
This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms:
Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
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
- •Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days
- •Presence of lymphedema in the lower extremity for at least 14 days
排除标准
- •Pregnant women or women of childbearing potential not on contraception
- •Previous use of the pneumatic compression device
- •Class IV congestive heart failure
结局指标
主要结局
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
时间窗: 30 days
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
次要结局
未报告次要终点