Comparison of Treatments in Venous Insufficiency

Venous Insufficiency Clinical Trial

Official title:

The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298908
• Other study ID #: Version 1.0 - Sep 6th, 2006
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: January 6, 2016
• Start date: October 2007
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Procedure:
• Operative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
• 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.
• 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.

Locations

Country	Name	City	State
Finland	Department of Vascular Surgery, Helsinki University Central Hospital	Helsinki	HUS
Finland	Department of Vascular Surgery, Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization or reflux of the treated venous trunk	Results will be verified by Duplex scanning	at 1 and 12 months	No
Secondary	Symptom relief	Symptoms will be evaluated by using CEAP-classification and degree of disability	at 1 and 12 months	No
Secondary	Complications related to procedure	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	Yes
Secondary	Quality of life	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	No