Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 5:49 AM
Study NCT ID:
NCT01615692
Status:
WITHDRAWN
Last Update Posted:
2018-04-18
First Post:
2012-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The 36-month Extension to Follow up Sub Study
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Organization:
Study Overview
Official Title:
The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sub study was not pursued as overall trial was negative
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.
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) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISRCTN71334751; NCT00143598 | REGISTRY | ISRCTN; Clinicaltrials.gov | View |