Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-07-06
2023-09-25
Brief Summary
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Detailed Description
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* Improves clinical and patient reported outcomes
* Is a good use of time and costs (efficient)
* Provides benefits that outweigh the cost of buying the IPC equipment
This study will recruit 40 patients with lymphoedema to use IPC daily at home for 12-weeks alongside their usual care. Information will be collected before and after the study including clinical measures (swelling, skin problems), patient reported outcomes (symptoms, quality of life) and experience. The study will compare the costs of procuring the IPC equipment with any benefits gained or costs avoided (less infections or hospital care). Participants will also be offered the chance to talk about their experiences of using IPC during an interview. Findings will be shared by publication and presentation. If the benefits are shown, lymphoedema services might be able to provide IPC for routine use at home through Value-Based procurement.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All participants
All participants will use IPC daily at home for 12 weeks alongside usual and standard care
LymphAssistTM Professional
An intermittent pneumatic compression (IPC) device that mimics manual lymphatic drainage. Participants use the device daily for 12 weeks alongside their usual and standard lymphoedema care
Interventions
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LymphAssistTM Professional
An intermittent pneumatic compression (IPC) device that mimics manual lymphatic drainage. Participants use the device daily for 12 weeks alongside their usual and standard lymphoedema care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known to local lymphoedema services and receiving ongoing treatment for their lymphoedema
* Age 18 and over
* Able to given informed written consent
* Able to safely use the Pump, following written and / or verbal instruction in English or Welsh
Exclusion Criteria
* Truncal / root of extremity oedema
* Known or suspected deep vein thrombosis
* Known or suspected pulmonary embolism
* Thrombophlebitis
* Active or suspected cellulitis
* Severe peripheral neuropathy
* Uncontrolled or severe congestive heart failure
* Pulmonary oedema
* Ischaemic vascular disease
* Active cancer / metastases affecting the area of lymphoedema / undergoing cancer treatment
* Untreated ulcer / wounds
* Urinary of faecal incontinence (for patients with lower limb lymphoedema only)
* History of clostridium difficile
* Unable to communicate in English or Welsh
18 Years
ALL
No
Sponsors
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Lymphoedema Wales Clinical Network
UNKNOWN
Swansea University
OTHER
Huntleigh Healthcare Ltd
INDUSTRY
Swansea Bay University Health Board
OTHER
Responsible Party
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Principal Investigators
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Marie Gabe-Walters, PhD
Role: PRINCIPAL_INVESTIGATOR
Lymphoedema Wales
Locations
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Swansea Bay University Health Board
Swansea, , United Kingdom
Countries
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Other Identifiers
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LymphAssist at home Protocol
Identifier Type: -
Identifier Source: org_study_id
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