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

Postphlebitic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182208
• Other study ID #: CTMG-2005-VENOPTS
• Secondary ID: Health Canada No
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 21, 2008
• Start date: May 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2008
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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}

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome

Intervention

Device:
• Veno-device (Venowave)

Locations

Country	Name	City	State
Canada	Henderson Research Centre	Hamilton	Ontario
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success measured with the Global Rating Instrument
Secondary	PTS-CCS questionnaire
Secondary	Villalta Scale
Secondary	Veines Quality of Life Questionnaire