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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182208
First Posted: September 16, 2005
Last Update Posted: July 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health Canada
Information provided by:
McMaster University
  Purpose
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.

Condition Intervention Phase
Postphlebitic Syndrome Device: Veno-device (Venowave) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Clinical Success measured with the Global Rating Instrument

Secondary Outcome Measures:
  • PTS-CCS questionnaire
  • Villalta Scale
  • Veines Quality of Life Questionnaire

Estimated Enrollment: 32
Study Start Date: May 2004
Study Completion Date: December 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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}
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182208


Locations
Canada, Ontario
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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
  More Information

ClinicalTrials.gov Identifier: NCT00182208     History of Changes
Other Study ID Numbers: CTMG-2005-VENOPTS
Health Canada No.:64844
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: July 22, 2008
Last Verified: July 2008

Keywords provided by McMaster University:
PTS
Post phlebitic Syndrome
Activities of Daily Living
Quality of Life

Additional relevant MeSH terms:
Syndrome
Postthrombotic Syndrome
Postphlebitic Syndrome
Disease
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases