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

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182208
First received: September 12, 2005
Last updated: July 21, 2008
Last verified: July 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00182208     History of Changes
Other Study ID Numbers: CTMG-2005-VENOPTS, Health Canada No.:64844
Study First Received: September 12, 2005
Last Updated: July 21, 2008
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014