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

Phase 3

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT00426075
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Primary Completion: 2007-11
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua; 🇮🇹 Padua, Italy