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

Phase 3

Completed

• Conditions: Postphlebitic Syndrome

• Registration Number: NCT00182208
• Lead Sponsor: Hamilton Health Sciences Corporation

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 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}

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2005-12
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-21
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical Success measured with the Global Rating Instrument

Secondary Outcome Measures

Name	Time	Method
PTS-CCS questionnaire
Villalta Scale
Veines Quality of Life Questionnaire

Trial Locations

Locations (2)

Henderson Research Centre; 🇨🇦 Hamilton, Ontario, Canada

Sir Mortimer B. Davis Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada