Comparison of Treatments in Venous Insufficiency

January 6, 2016 updated by: Maarit Venermo, Helsinki University Central Hospital

The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Department of Vascular Surgery, Tampere University Hospital
    • HUS
      • Helsinki, HUS, Finland, 00029
        • Department of Vascular Surgery, Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with chronic superficial vein insufficiency
  • patient must be 20-70 years old
  • degree of difficulty of vein insufficiency C2-C4
  • average diameter of refluxing great saphenous vein 4 -10 mm
  • patient is agreeable to the study

Exclusion Criteria:

  • peripheral atherosclerotic occlusive disease
  • lymphoedema
  • severe concomitant disease
  • venous ulcers or unclassified skin changes
  • BMI more than 40
  • pregnancy
  • allergy to the foam used in sclerotherapy or to local anaesthetics
  • coagulation disorder
  • bilateral vein insufficiency (equal symptoms)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Operative treatment
vein stripping
Procedure: Operative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
Other Names:
  • Vein stripping
Other: Laser ablation
Ultrasound guided laser ablation
Procedure: Laser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
Other Names:
  • Ultrasound guided laser ablation
Other: Foam sclerotherapy
Ultrasound guided foam sclerotherapy
Procedure: Foam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Other Names:
  • Ultrasound guided foam sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recanalization or reflux of the treated venous trunk
Time Frame: at 1 and 12 months
Results will be verified by Duplex scanning
at 1 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom relief
Time Frame: at 1 and 12 months
Symptoms will be evaluated by using CEAP-classification and degree of disability
at 1 and 12 months
Complications related to procedure
Time Frame: at 1 and 12 months
At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded.
at 1 and 12 months
Quality of life
Time Frame: at 1 and 12 months
Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life)
at 1 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Maarit Venermo, MD,PhD, Department of Vascular Surgery, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.0 - Sep 6th, 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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