Comparison of Treatments in Venous Insufficiency

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01298908
First received: February 17, 2011
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Venous Insufficiency
Procedure: Operative treatment
Procedure: Laser ablation
Procedure: Foam sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Recanalization or reflux of the treated venous trunk [ Time Frame: at 1 and 12 months ] [ Designated as safety issue: No ]
    Results will be verified by Duplex scanning


Secondary Outcome Measures:
  • Symptom relief [ Time Frame: at 1 and 12 months ] [ Designated as safety issue: No ]
    Symptoms will be evaluated by using CEAP-classification and degree of disability

  • Complications related to procedure [ Time Frame: at 1 and 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Quality of life [ Time Frame: at 1 and 12 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 231
Study Start Date: October 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vein stripping
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 Name: Ultrasound guided laser ablation
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 Name: Ultrasound guided foam sclerotherapy

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298908

Locations
Finland
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Department of Vascular Surgery, Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Maarit Venermo, MD,PhD Department of Vascular Surgery, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Maarit Venermo, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01298908     History of Changes
Other Study ID Numbers: Version 1.0 - Sep 6th, 2006
Study First Received: February 17, 2011
Last Updated: October 1, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
varicose veins, oedema

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014