Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

NCT03856281 | Completed

• 1 other identifier: IMPRESS II
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoedema of Leg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Myoton Scores

  5 weeks

• Quality of Life Scores

  5 weeks

Study Arms (2)

Intervention Group A

EXPERIMENTAL

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.

Device: Intermittent Pneumatic Compression

Intervention Group B

EXPERIMENTAL

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.

Device: Intermittent Pneumatic Compression

Interventions

Intermittent Pneumatic Compression DEVICE

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

Also known as: LymphAssist

Intervention Group A; Intervention Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or over,
• Able to provide written consent,
• Confirmed diagnosis of lower limb ISL stage II or III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• University of South Wales: collaborator

Study Sites (1)

Dewi Sant Hospital

Pontypridd, CF37 1LB, United Kingdom

Location

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Mark Williams, PhD

  University of South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: July 10, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: January 27, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)