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Completed

NCT Number: NCT03825263

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, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dewi Sant Hospital

Pontypridd, RCT, CF37 1LB, United Kingdom

About this study

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.

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

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.

Treatment and study plan

Intermittent Pressure Compression

Device

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.

Other names: Lymphassist

Primary outcomes

  1. Lower Limb Volume

    Time frame: 3 and 6 months of treatment

    Change in limb volume

Secondary outcomes

  1. Assessment of IPC use on the Quality of Life: QOL Scores

    Time frame: 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.

  2. Use of Perometer

    Time frame: 6 months

    Comparison of limb volume measurement methods

Sponsors and collaborators

Lead sponsor

University of South Wales

Other

Collaborators

  • Cwm Taf University Health Board (NHS)

Registry information

Official study title

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

Acronym: IMPRESS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

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.

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