Back to resultsEvaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Primary Purpose
Postphlebitic Syndrome
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Veno-device (Venowave)
Sponsored by
About this trial
This is an interventional treatment trial for Postphlebitic Syndrome focused on measuring PTS, Post phlebitic Syndrome, Activities of Daily Living, Quality of Life
Eligibility 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
Sites / Locations
- Henderson Research Centre
- Sir Mortimer B. Davis Jewish General Hospital
Outcomes
Primary Outcome Measures
Clinical Success measured with the Global Rating Instrument
Secondary Outcome Measures
PTS-CCS questionnaire
Villalta Scale
Veines Quality of Life Questionnaire
Full Information
NCT ID
NCT00182208
First Posted
September 12, 2005
Last Updated
July 21, 2008
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Health Canada
1. Study Identification
Unique Protocol Identification Number
NCT00182208
Brief Title
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Official Title
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Health Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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}
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postphlebitic Syndrome
Keywords
PTS, Post phlebitic Syndrome, Activities of Daily Living, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Veno-device (Venowave)
Primary Outcome Measure Information:
Title
Clinical Success measured with the Global Rating Instrument
Secondary Outcome Measure Information:
Title
PTS-CCS questionnaire
Title
Villalta Scale
Title
Veines Quality of Life Questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin O'Donnell, MB MRCPI
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan R Kahn, MD FRCPC
Organizational Affiliation
Department of Medicine McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henderson Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
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