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

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ClinicalTrials.gov Identifier: NCT03856281
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
University of South Wales
Information provided by (Responsible Party):
Cwm Taf University Health Board (NHS)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoedema of Leg Device: Intermittent Pneumatic Compression Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Intervention Group A
LymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period.
Device: Intermittent Pneumatic Compression
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
Other Name: LymphAssist

Experimental: Intervention Group B
Sequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period.
Device: Intermittent Pneumatic Compression
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
Other Name: LymphAssist




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (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:

  • • 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.

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): NCT03856281


Contacts
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Contact: Nyree Dunn 07889556344 nyree.dunn@southwales.ac.uk
Contact: Mark Williams, PhD mark.williams@southwales.ac.uk

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

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Responsible Party: Cwm Taf University Health Board (NHS)
ClinicalTrials.gov Identifier: NCT03856281     History of Changes
Other Study ID Numbers: IMPRESS II
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: February 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