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ESGVS: Sclerotherapy With Lauromacrogol

Primary Purpose

Venous Insufficiency, Saphenous Vein

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
lauromacrogol
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring lauromacrogol, Sclerotherapy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Center of Vascular Medecine - 7 rue Lesdiguières

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2006
Last Updated
July 5, 2006
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00348764
Brief Title
ESGVS: Sclerotherapy With Lauromacrogol
Official Title
Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency, Saphenous Vein
Keywords
lauromacrogol, Sclerotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lauromacrogol
Primary Outcome Measure Information:
Title
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.
Secondary Outcome Measure Information:
Title
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DIAMAND Jean Marc
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Vascular Medecine - 7 rue Lesdiguières
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10204659
Citation
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.
Results Reference
background
PubMed Identifier
9356628
Citation
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.
Results Reference
background
PubMed Identifier
10515291
Citation
Barro C, Bosson JL, Pernod G, Carpentier PH, Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalized patients. Thromb Res. 1999 Sep 1;95(5):263-9. doi: 10.1016/s0049-3848(99)00042-0. No abstract available.
Results Reference
background
PubMed Identifier
14638561
Citation
Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.
Results Reference
background
PubMed Identifier
14618112
Citation
Bosson JL, Labarere J, Barrellier MT, Belmin J, Couturier P, Le Roux P, Sevestre MA; Association pour la Promotion de l'Angiologie Hospitaliere (APAH). [Practice guidelines for the prevention of venous thromboembolism in elderly patients hospitalized in subacute care and rehabilitation facilities (short text). Association for the Promotion of Hospital Angiology]. J Mal Vasc. 2003 Oct;28(4):209-18. No abstract available. French.
Results Reference
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ESGVS: Sclerotherapy With Lauromacrogol

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