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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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}
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: Clinical Success measured with the Global Rating Instrument

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PTS-CCS questionnaire
  • Villalta Scale
  • Veines Quality of Life Questionnaire


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: September 12, 2005
Date Started: May 2004
Date Completion:
Last Updated: July 21, 2008
Last Verified: July 2008