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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoedema of Leg
• Intervention / Treatment: Device: Intermittent Pneumatic Compression

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Pontypridd, United Kingdom, CF37 1LB
    • Dewi Sant Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Intermittent Pneumatic Compression; Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period; Other Names: LymphAssist
EXPERIMENTAL: 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.	Device: Intermittent Pneumatic Compression; Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period; Other Names: LymphAssist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myoton Scores	The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D)	5 weeks
Quality of Life Scores	The effect IPC has on quality of life scores - raw score created from a series of Likert Scales	5 weeks

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)
• Collaborators: University of South Wales

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2018
• Primary Completion (ACTUAL): December 10, 2019
• Study Completion (ACTUAL): December 10, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: IMPRESS II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No