Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Not Applicable

Completed

• Conditions: Lymphoedema
• Interventions: Device: Intermittent Pressure Compression

• Registration Number: NCT03825263
• Lead Sponsor: University of South Wales

Brief Summary

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

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 Timeline

• Study Start: 2017-05-10
• Primary Completion: 2018-01-17
• Study Completion: 2018-02-28
• Status Verified: 2019-01
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intermittent Pressure Compression	Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment

Primary Outcome Measures

Name	Time	Method
Lower Limb Volume	3 and 6 months of treatment	Change in limb volume

Secondary Outcome Measures

Name	Time	Method
Assessment of IPC use on the Quality of Life: QOL Scores	3 and 6 months	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.
Use of Perometer	6 months	Comparison of limb volume measurement methods

Trial Locations

Locations (1)

Dewi Sant Hospital; 🇬🇧 Pontypridd, RCT, United Kingdom