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

This study has been completed.
Information provided by:
University of Padova Identifier:
First received: January 23, 2007
Last updated: June 9, 2008
Last verified: June 2008
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 Intervention Phase
Deep Vein Thrombosis Device: Elastic stockings Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University of Padova:

Study Start Date: January 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: January 23, 2007
Last Updated: June 9, 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 processed this record on August 22, 2017