Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Cwm Taf University Health Board (NHS)50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoedema of Leg

Interventions

Intermittent Pneumatic CompressionDEVICE

Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 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: * • 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.

Locations (1)

Dewi Sant Hospital

Pontypridd, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 5 weeks

Secondary Outcomes

Myoton Scores

The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D)

Time frame: 5 weeks

Quality of Life Scores

The effect IPC has on quality of life scores - raw score created from a series of Likert Scales

Time frame: 5 weeks

Data from ClinicalTrials.gov

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