Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

Lymphoedema Clinical Trial

— IMPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825263
• Other study ID #: IMPRESS
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: January 2019
• Source: University of South Wales
• 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphoedema

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Dewi Sant Hospital	Pontypridd	RCT

Sponsors (2)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Limb Volume	Change in limb volume	3 and 6 months of treatment
Secondary	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
Secondary	Use of Perometer	Comparison of limb volume measurement methods	6 months