Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lower Limb 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, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.
详细描述
This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.
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
- •Age 18 or over,
- •Able to provide written consent,
- •Confirmed diagnosis of lower limb ISL stage II or III.
排除标准
- •Any of these conditions
- •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.
研究组 & 干预措施
Control
Participants receive normal treatment
Intervention
Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment
干预措施: Intermittent Pressure Compression (Device)
结局指标
主要结局
Lower Limb Volume
时间窗: 3 and 6 months of treatment
Change in limb volume
次要结局
- Assessment of IPC use on the Quality of Life: QOL Scores(3 and 6 months)
- Use of Perometer(6 months)