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, 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.

Detailed Description
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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.

Official Title
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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study

Conditions
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Lymphoedema

Intervention / Treatment
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* Device: Intermittent Pressure 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: 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.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Observational control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants receive normal treatment | |
| Experimental: Intervention<br>Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment | Device: Intermittent Pressure Compression<br>* The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.<br>* Other names: Lymphassist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Limb Volume | Change in limb volume | 3 and 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of IPC use on the Quality of Life: QOL Scores | Change in QOL Scores. Using the Quality of LifeEnjoyment and Satisfication Questionairre short form (Q-LES-Q-SF) with 14 items. Score range is from 14 to 70. | 3 and 6 months | 
| Use of Perometer | Comparison of limb volume measurement methods | 6 months |