NCT00143598

The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome

The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.

Detailed description

The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) could be helpful in preventing PTS, however data on their effectiveness are scarce and conflicting. Comparison(s): Knee-length, 30-40 mm Hg (Class II), graduated ECS worn on the DVT-affected leg daily for 2 years compared to knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily for 2 years.

Conditions

• Deep Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	Knee-length, graduated elastic compression stocking	Worn daily for 2 years, 30-40 mm Hg
DEVICE	Knee-length, placebo stocking	Worn daily for two years

Timeline

• Start date: 2004-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2005-09-02
• Last updated: 2014-08-18
• Results posted: 2014-08-18

Locations

25 sites across 2 countries: United States, Canada