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

July 21, 2008 updated by: Hamilton Health Sciences Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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}

Study Type

Interventional

Enrollment

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Henderson Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B. Davis Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical Success measured with the Global Rating Instrument

Secondary Outcome Measures

Outcome Measure
PTS-CCS questionnaire
Villalta Scale
Veines Quality of Life Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Health Canada

Investigators

  • Principal Investigator: Martin O'Donnell, MB MRCPI, Hamilton Health Sciences Corporation
  • Principal Investigator: Susan R Kahn, MD FRCPC, Department of Medicine McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2008

Last Update Submitted That Met QC Criteria

July 21, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-2005-VENOPTS
  • Health Canada No.:64844

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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