NCT03856281

Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Cwm Taf University Health Board (NHS) · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoedema of Leg

Interventions

Type	Name	Description
DEVICE	Intermittent Pneumatic Compression	Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-02-27
• Last updated: 2020-01-27

Locations

1 site across 1 country: United Kingdom