Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS)

Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study

The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.

Study Overview

• Status: Completed
• Conditions: Lymphoedema
• Intervention / Treatment: Device: Intermittent Pressure Compression

Detailed Description

This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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:

Any of these conditions

• 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants receive normal treatment
Experimental: Intervention; Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment	Device: Intermittent Pressure Compression; The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.; Other Names: Lymphassist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Limb Volume	Change in limb volume	3 and 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of IPC use on the Quality of Life: QOL Scores	Change in QOL Scores. Using the Quality of LifeEnjoyment and Satisfication Questionairre short form (Q-LES-Q-SF) with 14 items. Score range is from 14 to 70.	3 and 6 months
Use of Perometer	Comparison of limb volume measurement methods	6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Dunn N, Williams EM, Fishbourne M, Dolan G, Davies JH. Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study. Pilot Feasibility Stud. 2019 Sep 30;5:113. doi: 10.1186/s40814-019-0496-4. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): January 17, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

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

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