Back to resultsFull-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Elastic stockings
Sponsored by
About this trial
This is an interventional prevention trial for Deep Vein Thrombosis focused on measuring Deep vein thrombosis of the lower extremities
Eligibility 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
Sites / Locations
- Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00426075
Brief Title
Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Padova
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
Deep vein thrombosis of the lower extremities
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Elastic stockings
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Prandoni, MD, PhD
Organizational Affiliation
Department of Medical and Surgical Sciences, University of Padua, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
City
Padua
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22180438
Citation
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.
Results Reference
derived
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Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
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