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

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Padua, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastic stockings

Device

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2007
First posted: Jan 24, 2007
Registry last updated: Jun 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed