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Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02010723
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kornelia Boehler, Medical University of Vienna
  Purpose
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.

Condition Intervention Phase
Varicose Veins Procedure: surgery Drug: sclerotherapy with aethoxysclerol foam Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Resource links provided by NLM:


Further study details as provided by Kornelia Boehler, Medical University of Vienna:

Primary Outcome Measures:
  • duplex-sonographic recurrence after 3 years [ Time Frame: 3 years ]
    duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.


Secondary Outcome Measures:
  • duplex-sonographic recurrence after 1 year [ Time Frame: 1 year ]
    duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the AAGSV in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group

  • clinical recurrence [ Time Frame: 1 year and 3 years ]
    Clinical recurrence is evaluated by determination of the current Clinical-Etiology- Anatomy- Pathophysiology (CEAP) classification and reappearance of new varicose veins in the treated area

  • neovascularisation in the saphenofemoral junction [ Time Frame: 1 year and 3 years ]

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Procedure: surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Experimental: sclerotherapy
foam sclerotherapy with aethoxysclerol foam
Drug: sclerotherapy with aethoxysclerol foam
foam sclerotherapy with aethoxysclerol foam

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • reflux in anterior accessory great saphenous vein (AAGSV) > 0,5 sek

Exclusion Criteria:

  • concomitant reflux in great saphenous vein (GSV)
  • reflux in the deep venous system (postthrombotic syndrome)
  • acute thrombosis
  • hypercoagulability
  • allergy to aethoxysclerol or local anesthetics
  • immobility
  • open foramen ovale
  • bacterial infection of the skin
  • pregnancy and breast feeding
  • peripheral arterial occlusive disease III, IV (PAOD)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010723


Locations
Austria
Medical University of Vienna, Department of General Dermatology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Kornelia Boehler, MD Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
  More Information

Publications:
Responsible Party: Kornelia Boehler, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02010723     History of Changes
Other Study ID Numbers: 20060508
255/2006 ( Other Identifier: Ethikkommission medical university of vienna )
First Submitted: November 18, 2013
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by Kornelia Boehler, Medical University of Vienna:
varicosis
foam sclerotherapy
surgery

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions


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