Skip to main content
OpenTrials
Completed

NCT Number: NCT03856281

Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dewi Sant Hospital

Pontypridd, CF37 1LB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intermittent pneumatic compression

Device

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

Other names: LymphAssist

Primary outcomes

  1. Leg Volume

    Time frame: 5 weeks

    Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls

Secondary outcomes

  1. Myoton Scores

    Time frame: 5 weeks

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

  2. Quality of Life Scores

    Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

Cwm Taf University Health Board (NHS)

Other Gov

Collaborators

  • University of South Wales

Registry information

Official study title

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

Acronym: IMPRESS II

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.