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CompletedNCT00182208Updated Jul 22, 2008

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

A Phase 3 interventional study of Veno-device (Venowave) in Postphlebitic Syndrome, sponsored by Hamilton Health Sciences Corporation. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-07-22.

Sponsored by Hamilton Health Sciences Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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}

02

Conditions studied

  • Postphlebitic Syndrome

Keywords

  • PTS
  • Post phlebitic Syndrome
  • Activities of Daily Living
  • Quality of Life
03

In context

Postthrombotic Syndrome

65 studies on the registry are indexed under Postthrombotic Syndrome; 22 are open to participants now.

This study's enrollment of 32 is below the median of 89 across 40 interventional studies indexed under Postthrombotic Syndrome.

Browse Postthrombotic Syndrome studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
32 participants

Interventions

  • DeviceVeno-device (Venowave)
06

What researchers measure

Primary outcomes

  1. Clinical Success measured with the Global Rating Instrument

Secondary outcomes

  1. PTS-CCS questionnaire

  2. Villalta Scale

  3. Veines Quality of Life Questionnaire

07

Study locations

2 sites
  • Henderson Research Centre
    Hamilton, Ontario L8V 1C3, Canada
  • Sir Mortimer B. Davis Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00182208
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
Health Canada
First posted
Sep 16, 2005
Start date
May 2004
Primary completion
Jun 2005
Completion
Dec 2005
Last update
Jul 22, 2008

Study contacts

Martin O'Donnell, MB MRCPI
principal investigator · Hamilton Health Sciences Corporation
Susan R Kahn, MD FRCPC
principal investigator · Department of Medicine McGill University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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