Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2004-03-31
2006-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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lauromacrogol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
25 Years
75 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Principal Investigators
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DIAMAND Jean Marc
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Center of Vascular Medecine - 7 rue Lesdiguières
Grenoble, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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DCIC 03 38
Identifier Type: -
Identifier Source: org_study_id