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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS)

U

University of South Wales

Status

Completed

Conditions

Lymphoedema

Treatments

Device: Intermittent Pressure Compression

Study type

Interventional

Funder types

Other

Identifiers

NCT03825263
IMPRESS

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Control
No Intervention group
Description:
Participants receive normal treatment
Intervention
Experimental group
Description:
Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment
Treatment:
Device: Intermittent Pressure Compression

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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