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

NCT00426075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2008-06-10

No results posted yet for this 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.

Conditions

  • Deep Vein Thrombosis

Interventions

DEVICE

Elastic stockings

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Paolo Prandoni, MD, PhD · Department of Medical and Surgical Sciences, University of Padua, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00426075 on ClinicalTrials.gov