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

S

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase

Completed
Phase 3

Conditions

Deep Venous Thrombosis

Treatments

Device: Knee-length, graduated elastic compression stocking
Device: Knee-length, placebo stocking

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00143598
ISRCTN71334751 (Registry Identifier)
MCT-63142

Details and patient eligibility

About

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.

Full 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.

Enrollment

806 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
  • Who have no contraindications to standard treatment with heparin and/or warfarin, and
  • Who provide informed consent to participate

Exclusion criteria

  • Contraindication to compression stockings
  • Limited lifespan (estimated < 6 months)
  • Geographic inaccessibility preventing return for follow-up visits
  • Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
  • Treatment of acute DVT with thrombolytic agents

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

806 participants in 2 patient groups, including a placebo group

Active ECS
Active Comparator group
Description:
Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Treatment:
Device: Knee-length, graduated elastic compression stocking
Placebo ECS
Placebo Comparator group
Description:
Placebo stockings with identical appearance to Active ECS and with \< 5 mm Hg compression at the ankle.
Treatment:
Device: Knee-length, placebo stocking

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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