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

This study has been completed.

Sponsor:

Information provided by:

University of Padova

ClinicalTrials.gov Identifier:

NCT00426075

First received: January 23, 2007

Last updated: June 9, 2008

Last verified: June 2008

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

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)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426075

Locations

Italy
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Padua, Italy, 35128

Sponsors and Collaborators

University of Padova

Investigators

Principal Investigator:

Paolo Prandoni, MD, PhD

Department of Medical and Surgical Sciences, University of Padua, Italy

More Information

No publications provided by University of Padova

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. Epub 2011 Dec 16.

Responsible Party:	Paolo Prandoni, Department of Medical and Surgical Sciences, University of Padua
ClinicalTrials.gov Identifier:	NCT00426075 History of Changes
Other Study ID Numbers:	11/98
Study First Received:	January 23, 2007
Last Updated:	June 9, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Padova:

Deep vein thrombosis of the lower extremities

Additional relevant MeSH terms:

Postthrombotic Syndrome
Postphlebitic Syndrome
Thrombosis
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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