Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Lymphoedema of Leg Clinical Trial

— IMPRESS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856281
• Other study ID #: IMPRESS II
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: February 2019
• Source: Cwm Taf University Health Board (NHS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18 or over,

• Able to provide written consent,

• Confirmed diagnosis of lower limb ISL stage II or III.

Exclusion Criteria:

• • Unable to provide written consent

• 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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphoedema of Leg

Intervention

Device:
• Intermittent Pneumatic Compression
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Locations

Country	Name	City	State
United Kingdom	Dewi Sant Hospital	Pontypridd

Sponsors (2)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)	University of South Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg Volume	Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls	5 weeks
Secondary	Myoton Scores	The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D)	5 weeks
Secondary	Quality of Life Scores	The effect IPC has on quality of life scores - raw score created from a series of Likert Scales	5 weeks