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

University of Padova

Status and phase: Completed; Phase 3

Conditions: Deep Vein Thrombosis

Treatments: Device: Elastic stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT00426075

11/98

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)