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Trial record 12 of 288 for:    Lymphedema

Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03825263
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Cwm Taf University Health Board (NHS)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphoedema Device: Intermittent Pressure Compression Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Observational control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
No Intervention: Control
Participants receive normal treatment
Experimental: Intervention
Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment
Device: Intermittent Pressure Compression
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 Name: Lymphassist




Primary Outcome Measures :
  1. Lower Limb Volume [ Time Frame: 3 and 6 months of treatment ]
    Change in limb volume


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825263


Locations
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United Kingdom
Dewi Sant Hospital
Pontypridd, RCT, United Kingdom, CF37 1LB
Sponsors and Collaborators
University of South Wales
Cwm Taf University Health Board (NHS)
Investigators
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Principal Investigator: Mark Williams, Phd University of South Wales

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Responsible Party: University of South Wales
ClinicalTrials.gov Identifier: NCT03825263     History of Changes
Other Study ID Numbers: IMPRESS
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases