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