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

January 23, 2007
June 9, 2008
January 2006
November 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00426075 on ClinicalTrials.gov Archive Site
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Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
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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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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Deep Vein Thrombosis
Device: Elastic stockings
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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. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2007   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00426075
11/98
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Paolo Prandoni, Department of Medical and Surgical Sciences, University of Padua
University of Padova
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Principal Investigator: Paolo Prandoni, MD, PhD Department of Medical and Surgical Sciences, University of Padua, Italy
University of Padova
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP