Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Leg Volume
研究概览
简要总结
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.
详细描述
The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over,
- •Able to provide written consent,
- •Confirmed diagnosis of lower limb ISL stage II or III.
排除标准
- •• Unable to provide written consent
- •Severe congestive heart failure
- •Severe skin problems, lower limb ulcers or wounds.
- •Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol.
- •Non-pitting chronic lymphoedema.
- •Known or suspected deep vein thrombosis.
- •Pulmonary embolism.
- •Thrombophlebitis.
- •Acute inflammation of the skin (erysipelas, cellulitis).
- •Uncontrolled/severe cardiac failure.
- •Pulmonary oedema.
- •Ischaemic vascular disease.
- •Active cancer diagnosis.
- •Active metastatic diseases affecting the oedematous region.
- •Oedema at the root of the extremity or truncal oedema.
- •Severe peripheral neuropathy.
结局指标
主要结局
Leg Volume
时间窗: 5 weeks
Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls
次要结局
- Myoton Scores(5 weeks)
- Quality of Life Scores(5 weeks)