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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014