ESGVS: Sclerotherapy With Lauromacrogol | NCT00348764

Studies
ESGVS: Sclerotherapy With Lauromacrogol

NCT00348764

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Jul 6, 2006Estimated

Enrollment

150

Phase

Phase 3

Conditions

Venous Insufficiency
Saphenous Vein

Interventions

lauromacrogol

Countries

France

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

Jul 2006

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

Mar 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 6, 2006Estimated

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

Jul 5, 2006

Last Update Posted Date

Jul 6, 2006Estimated

Description Module

Brief Summary

To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

Detailed Description

A multicenter randomized double blind study to evaluate the efficacy and the tolerance of echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great Saphenous Vein (GSV) insufficiency.

One hundred fifty eligible patients will be recruited during 6 months from 9 study centers with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2 ,and 3 years.

After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3% Lauromacrogol 400 foam (ratio 1:1).

Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years.

Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional injection of 4 ml of foam can be performed if needed.

Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2, and 3 years.

The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be a criterion of therapeutic failure.

The therapeutic success or failure criteria are evaluated by a non investigator angiologist for 5 patients randomized from each investigational site at 1, 2 and 3 years.

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

150

Name	Type	Description	Arm Group Labels	Other Names
lauromacrogol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.

Secondary Outcomes

Measure	Description	Time Frame
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

25 - 75 years
Hawaii CEAP classification : C2-5 Ep, As2-3 Pr
Clinical Varicose veins C2, Edema C3, Skin changes C4, Healed ulcer C5
Etiology Ep Primary GSV insufficiency
As2-3: Ostial and or crural truncular GVS incompetence
Maximal inferior diameter of the leg GSV (patient in decubitus) between 4 and 8mm
Pr: reflux by echo doppler in orthostatism > 1 second
Information consent form signed by the investigator and the patient.

Exclusion Criteria:

deep venous reflux (CEAP: Ad)
Short saphenous vein or non saphenous network insufficiency (CEAP: A4-5)
Clinical class: C1 or C6
Recurrent GSV varicose veins after stripping
Thrombophilia or antecedent of deep vein thrombosis
Psychiatric disorders
Known allergy to Lauromacrogol or to one of its component
Arteriopathy. (IPS < 0.8)
Post-thrombotic disease
Chronic hepatoma
Renal insufficiency (creatinine > 150 micromol/l)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DIAMAND Jean Marc	Institut National de la Santé Et de la Recherche Médicale, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Vascular Medecine - 7 rue Lesdiguières		Grenoble		38000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10204659	Background	Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.
9356628	Background	Ferretti GR, Bosson JL, Buffaz PD, Ayanian D, Pison C, Blanc F, Carpentier F, Carpentier P, Coulomb M. Acute pulmonary embolism: role of helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs. Radiology. 1997 Nov;205(2):453-8. doi: 10.1148/radiology.205.2.9356628.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D011092	Polyethylene Glycols
D005026	Ethylene Glycols
D006018	Glycols
D000438	Alcohols