Full-Leg vs Below-Knee Elastic Stockings for Prevention o... | NCT00426075

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

NCT00426075

Sponsor

University of Padova

Status

Completed

Last Update Posted

Jun 10, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Deep Vein Thrombosis

Interventions

Elastic stockings

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 23, 2007

First Submission Date that Met QC Criteria

Jan 23, 2007

First Posted Date

Jan 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2008

Last Update Posted Date

Jun 10, 2008Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Elastic stockings	Device

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paolo Prandoni, MD, PhD	Department of Medical and Surgical Sciences, University of Padua, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua		Padua	Padua	35128	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22180438	Derived	Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D058128	Compression Bandages
D001458	Bandages
D004864	Equipment and Supplies