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

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. Identifier: NCT00182208
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 22, 2008
Health Canada
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Postphlebitic Syndrome Device: Veno-device (Venowave) Phase 3

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}

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
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
Study Start Date : May 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : December 2005

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

Secondary Outcome Measures :
  1. PTS-CCS questionnaire
  2. Villalta Scale
  3. Veines Quality of Life Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00182208

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

Layout table for additonal information Identifier: NCT00182208    
Other Study ID Numbers: CTMG-2005-VENOPTS
Health Canada No.:64844
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008
Keywords provided by McMaster University:
Post phlebitic Syndrome
Activities of Daily Living
Quality of Life
Additional relevant MeSH terms:
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Postthrombotic Syndrome
Postphlebitic Syndrome
Pathologic Processes
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Peripheral Vascular Diseases