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Completed

NCT Number: NCT00182208

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

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.

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Key information

Conditions

Postphlebitic Syndrome Cardiovascular Diseases Embolism and Thrombosis Peripheral Vascular Diseases Phlebitis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henderson Research Centre, Hamilton, Ontario, Canada

Loading trial locations.

About this study

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}

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veno-device (Venowave)

Device

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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Health Canada

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Jul 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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