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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS)

Primary Purpose

Lymphoedema

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intermittent Pressure Compression
Sponsored by
University of South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dewi Sant Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Participants receive normal treatment

Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment

Outcomes

Primary Outcome Measures

Lower Limb Volume
Change in limb volume

Secondary Outcome Measures

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.
Use of Perometer
Comparison of limb volume measurement methods

Full Information

First Posted
January 28, 2019
Last Updated
January 30, 2019
Sponsor
University of South Wales
Collaborators
Cwm Taf University Health Board (NHS)
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1. Study Identification

Unique Protocol Identification Number
NCT03825263
Brief Title
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
Acronym
IMPRESS
Official Title
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Wales
Collaborators
Cwm Taf University Health Board (NHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Observational control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive normal treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment
Intervention Type
Device
Intervention Name(s)
Intermittent Pressure Compression
Other Intervention Name(s)
Lymphassist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower Limb Volume
Description
Change in limb volume
Time Frame
3 and 6 months of treatment
Secondary Outcome Measure Information:
Title
Assessment of IPC use on the Quality of Life: QOL Scores
Description
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.
Time Frame
3 and 6 months
Title
Use of Perometer
Description
Comparison of limb volume measurement methods
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Williams, Phd
Organizational Affiliation
University of South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dewi Sant Hospital
City
Pontypridd
State/Province
RCT
ZIP/Postal Code
CF37 1LB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31583112
Citation
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.
Results Reference
derived

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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

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