Lymphoedema
Conditions
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.
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.
Interventions
DEVICEIntermittent 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.
Sponsors
Cwm Taf University Health Board (NHS)
University of South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Observational control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Limb Volume | 3 and 6 months of treatment | Change in limb volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of IPC use on the Quality of Life: QOL Scores | 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. |
| Use of Perometer | 6 months | Comparison of limb volume measurement methods |
Countries
United Kingdom
Outcome results
None listed