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NCT00426075 Clinical Trial

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

Deep Vein Thrombosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00426075
Other study ID # 11/98
Secondary ID
Status Completed
Phase Phase 3
First received January 23, 2007
Last updated June 9, 2008
Start date January 2006

Study information
Verified date June 2008
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Elastic stockings

Locations
Country Name City State
Italy Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua Padua

Sponsors (1)
Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

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