Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426075
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : June 10, 2008
Information provided by:
University of Padova

Brief Summary:
Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Device: Elastic stockings Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2006
Actual Primary Completion Date : November 2007

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • First episode of proximal deep vein thrombosis, as shown by compression ultrasound

Exclusion Criteria:

  • Previous ipsilateral deep vein thrombosis
  • Preexisting chronic venous insufficiency
  • Bilateral deep vein thrombosis
  • Life expectancy lower than 1 year
  • Severe arteriopathy of the lower limbs
  • Known allergy to elastic stockings
  • Lack of written informed consensus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426075

Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Padua, Italy, 35128
Sponsors and Collaborators
University of Padova
Principal Investigator: Paolo Prandoni, MD, PhD Department of Medical and Surgical Sciences, University of Padua, Italy

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paolo Prandoni, Department of Medical and Surgical Sciences, University of Padua Identifier: NCT00426075     History of Changes
Other Study ID Numbers: 11/98
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008

Keywords provided by University of Padova:
Deep vein thrombosis of the lower extremities

Additional relevant MeSH terms:
Venous Thrombosis
Postthrombotic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency