Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial

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

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.

Detailed Description

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Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}

Conditions

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Postphlebitic Syndrome

Keywords

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PTS Post phlebitic Syndrome Activities of Daily Living Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Veno-device (Venowave)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Past History of objectively documented deep vein thrombosis
* Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
* Over 18 years of age (and of either gender).
* Villalta score of greater than 14(i.e.severe post phlebitic syndrome)

Exclusion Criteria

* Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
* Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
* Active venous ulceration
* Baseline leg circumference greater than 50 cm (cuff will not fit subject)
* Symptomatic peripheral arterial disease Peripheral neuropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Martin O'Donnell, MB MRCPI

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Susan R Kahn, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine McGill University

Locations

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Henderson Research Centre

Hamilton, Ontario, Canada

Site Status

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Health Canada No.:64844

Identifier Type: -

Identifier Source: secondary_id

CTMG-2005-VENOPTS