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Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

NCT ID: NCT03825263

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Lymphoedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Observational control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Participants receive normal treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Intermittent Pressure Compression

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Lymphassist

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cwm Taf University Health Board (NHS)

OTHER_GOV

Sponsor Role collaborator

University of South Wales

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Williams, Phd

Role: PRINCIPAL_INVESTIGATOR

University of South Wales

Locations

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Dewi Sant Hospital

Pontypridd, RCT, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31583112 (View on PubMed)

Other Identifiers

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IMPRESS

Identifier Type: -

Identifier Source: org_study_id