NCT00182208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 22, 2008

Status Verified

July 1, 2008

Enrollment Period

1.1 years

First QC Date

September 12, 2005

Last Update Submit

July 21, 2008

Conditions

Postphlebitic Syndrome

Keywords

PTSPost phlebitic SyndromeActivities of Daily LivingQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Clinical Success measured with the Global Rating Instrument

Secondary Outcomes (3)

  • PTS-CCS questionnaire

  • Villalta Scale

  • Veines Quality of Life Questionnaire

Interventions

Veno-device (Venowave)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henderson Research Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Postphlebitic SyndromePostthrombotic Syndrome

Condition Hierarchy (Ancestors)

PhlebitisPeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVenous InsufficiencyVenous ThrombosisThrombosisEmbolism and Thrombosis

Study Officials

  • Martin O'Donnell, MB MRCPI

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

  • Susan R Kahn, MD FRCPC

    Department of Medicine McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Primary Completion

June 1, 2005

Study Completion

December 1, 2005

Last Updated

July 22, 2008

Record last verified: 2008-07

Locations

CA(2)