Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)

Conditions
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Lymphoedema of Leg

Intervention / Treatment
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* Device: Intermittent Pneumatic Compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or over, Able to provide written consent, Confirmed diagnosis of lower limb ISL stage II or III. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group A<br>LymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. | Device: Intermittent Pneumatic Compression<br>* Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period<br>* Other names: LymphAssist;|
| Experimental: Intervention Group B<br>Sequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. | Device: Intermittent Pneumatic Compression<br>* Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period<br>* Other names: LymphAssist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Volume | Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoton Scores | The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D) | 5 weeks | 
| Quality of Life Scores | The effect IPC has on quality of life scores - raw score created from a series of Likert Scales | 5 weeks |