Status:
COMPLETED
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
Lead Sponsor:
University of South Wales
Collaborating Sponsors:
Cwm Taf University Health Board (NHS)
Conditions:
Lymphoedema
Eligibility:
All Genders
18+ years
Phase:
NA
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 (Hu...
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 tri...
Eligibility Criteria
Inclusion
- Age 18 or over,
- Able to provide written consent,
- Confirmed diagnosis of lower limb ISL stage II or III.
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03825263
Start Date
May 10 2017
End Date
February 28 2018
Last Update
January 31 2019
Active Locations (1)
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1
Dewi Sant Hospital
Pontypridd, RCT, United Kingdom, CF37 1LB