The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00143598|
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Deep Venous Thrombosis||Device: Knee-length, graduated elastic compression stocking Device: Knee-length, placebo stocking||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||806 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Active Comparator: Active ECS
Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Device: Knee-length, graduated elastic compression stocking
Worn daily for 2 years, 30-40 mm Hg
Placebo Comparator: Placebo ECS
Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
Device: Knee-length, placebo stocking
Worn daily for two years
- Incidence of Post-thrombotic Syndrome (PTS) [ Time Frame: During 2-year follow up ]
- Severity of PTS, Including Incidence of Venous Ulcer [ Time Frame: 6-24 months. ]
Highest Villalta at or after 6 month visit
The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).
Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score.
- Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding [ Time Frame: During 2-year follow up ]
- Quality of Life [ Time Frame: 24 months ]
The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.
The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143598
|Principal Investigator:||Susan R. Kahn, M.D., M.Sc.||Sir Mortimer B. Davis - Jewish General Hospital|