Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

University of South Wales20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoedema

Interventions

Intermittent Pressure CompressionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dewi Sant Hospital

Pontypridd, RCT, United Kingdom

Outcomes

Primary Outcomes

Lower Limb Volume

Change in limb volume

Time frame: 3 and 6 months of treatment

Secondary Outcomes

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.

Time frame: 3 and 6 months

Use of Perometer

Comparison of limb volume measurement methods

Time frame: 6 months

Data from ClinicalTrials.gov

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