Compression Treatment of Superficial Vein Thrombosis | NCT01976637

Studies
Compression Treatment of Superficial Vein Thrombosis

NCT01976637

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 16, 2014Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Pain
Erythema
Thrombus Length
Quality of Life

Interventions

no compression
compression

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

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

Dec 2009

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 30, 2013

First Submission Date that Met QC Criteria

Nov 5, 2013

First Posted Date

Nov 6, 2013Estimated

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

Jan 15, 2014

Last Update Posted Date

Jan 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.

This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no compression	Experimental	no compression stockings worn during a 3 weeks period	Other: no compression
compression stockings	Active Comparator	compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks	Device: compression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no compression	Other	no compression stockings worn during the study	no compression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain assessed by VAS (cm)	change from baseline to week 3 at weekly intervals	at baseline, week 1, week 2, week 3

Secondary Outcomes

Measure	Description	Time Frame
skin erythema (cm2)	change from baseline to week 3 at weekly intervals	at baseline, week 1, week 2, week 3
duplex-sonographic change in thrombus length (cm)	change from baseline to week 3 at weekly intervals

Other Outcomes

Measure	Description	Time Frame
D-dimer ug/ml		at baseline and at week 3
platelet count		at baseline, day 7 and day14

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with superficial vein thrombosis of the leg,
thrombus extent of at least 5 cm confirmed by duplex sonography,
clinical signs of inflammation (pain, erythema)

Exclusion Criteria:

superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
concomitant deep vein thrombosis,
thrombophilia,
active malignoma,
immobility,
peripheral arterial occlusive disease,
superficial vein thrombosis after sclerotherapy
incision and clot expression
excessive leg configuration not covered by ready made compression stockings

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kornelia Böhler, MD	Medical University of Vienna, Department of General Dermatology	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Apr 16, 2015
Reset	May 8, 2015
Release	Mar 29, 2016
Reset	Apr 29, 2016

Submission Tracking

Estimated Results First Submitted Date

Apr 16, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 16, 2015			May 8, 2015
Mar 29, 2016

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D004890	Erythema

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012871	Skin Diseases

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