Dewi Sant Hospital
Pontypridd, CF37 1LB, United Kingdom
NCT Number: NCT03856281
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Pontypridd, CF37 1LB, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
Other names: LymphAssist
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
Time frame: 5 weeks
The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D)
Time frame: 5 weeks
The effect IPC has on quality of life scores - raw score created from a series of Likert Scales
Cwm Taf University Health Board (NHS)
Other Gov
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
Acronym: IMPRESS II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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