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

Last updated: June 9, 2008
Sponsor: University of Padova
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Claudication

Thrombosis

Treatment

N/A

Clinical Study ID

NCT00426075
11/98
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Study Start date:
January 01, 2006
Estimated Completion Date:

Connect with a study center

  • Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua

    Padua, 35128
    Italy

    Site Not Available

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