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

This study has been completed.

First Received: September 12, 2005 Last Updated: July 21, 2008 History of Changes

Sponsors and Collaborators:	Hamilton Health Sciences Health, Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182208

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
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

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

Health, Canada

Investigators

Principal Investigator:	Martin O'Donnell, MB MRCPI	Hamilton Health Sciences
Principal Investigator:	Susan R Kahn, MD FRCPC	Department of Medicine McGill University

More Information

No publications provided

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

Keywords provided by McMaster University:

PTS
Post phlebitic Syndrome
Activities of Daily Living
Quality of Life

Study placed in the following topic categories:

Embolism and Thrombosis
Peripheral Vascular Diseases
Embolism
Phlebitis
Venous Insufficiency
Vascular Diseases

Quality of Life
Venous Thrombosis
Postthrombotic Syndrome
Thrombosis
Postphlebitic Syndrome

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Disease
Vascular Diseases
Postthrombotic Syndrome
Thrombosis
Embolism and Thrombosis
Pathologic Processes

Syndrome
Venous Insufficiency
Phlebitis
Venous Thrombosis
Cardiovascular Diseases
Postphlebitic Syndrome

ClinicalTrials.gov processed this record on May 07, 2009