IMPRESS II
Research type
Research Study
Full title
Intermittent Pneumatic Compression for treating lower limb lymphoedema
IRAS ID
238241
Contact name
Mark Williams
Contact email
Sponsor organisation
Cwm Taf University Health Board Research & Development Department
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Lymphoedema is a chronic condition that causes swelling in the body due to a
build up of fluid. The consequences of lymphoedema are not only seen from a physical perspective but from a psychological perspective as well
The gold standard treatment for lymphoedema is Decongestive Lymphatic Therapy (DLT). There are four components to DLT; compression, skin care, exercise and lymph drainage. Unfortunately DLT isn't universally available and some patients find the compression therapy difficult to tolerate.
Intermittent pneumatic compression devices (IPC) offer an alternative treatment for compression bandages/garments as the device exerts a lower pressure to the limb. Huntleigh have developed am innovative IPC treatment regime (LymphAssist) which can be used in the home environment. It is anticipated that the use of this device could improve concordance of treatment.
The IMPRESS II study aims to look at the effectiveness of the LymphAssist in terms of changes in limb volume, impact on heaviness/tightness, pain scores and quality of life.
IMPRESS II is a randomised control trial study. Sixty eligible patients who consent to participate will be randomly assigned to intervention group A (n=30) or intervention group B (n=30). 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 a LymphAssist device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only, before being invited back into clinic to be randomised into either treatment arm. Each participant will then receive their IPC device and begin a 5 week treatment period. After the treatment period, they will return the device and be invited back for a follow up appointment at their convenience/at their routine clinic appointment. Each participant will remain in the study for 10 weeks excluding the follow up appointment, during which time their response to their lymphoedema treatments will be assessed.REC name
Wales REC 6
REC reference
18/WA/0114
Date of REC Opinion
29 Mar 2018
REC opinion
Further Information Favourable Opinion