Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

NCT ID: NCT03856281

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2019-12-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group A

LymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period.

Group Type: EXPERIMENTAL

Intermittent Pneumatic Compression

Intervention Type: DEVICE

Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Intervention Group B

Sequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period.

Group Type: EXPERIMENTAL

Intermittent Pneumatic Compression

Intervention Type: DEVICE

Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Interventions

Intermittent Pneumatic Compression

Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period

Intervention Type: DEVICE

Other Intervention Names

LymphAssist

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Wales

OTHER

Sponsor Role: collaborator

Cwm Taf University Health Board (NHS)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Wales

Locations

Dewi Sant Hospital

Pontypridd, , United Kingdom

Countries

United Kingdom

Other Identifiers

IMPRESS II

Identifier Type: -

Identifier Source: org_study_id