Delayed or Immediate Local Treatment of Veins

Varicose Veins Leg Clinical Trial

— DELICATVE  

Official title:

Delayed or Immediate Local Treatment of Varicose Veins

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03340246
• Other study ID #: DELICATVE
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.

This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 31, 2022
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Ultrasound verified insufficiency of great saphenous vein (GSV)

• GSV diameter 5-10 mm

• C2-C4 varicosities

• Most proximal insufficient branch in the distal thigh

• Written and signed informed consent

Exclusion Criteria:

• Peripheral arterial disease

• Body mass index >40

• Lymphoedema

• Known allergy to sclerosant

• Any known coagulopathy or history of deep vein thrombosis

• Severe illness

• Pregnancy

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins Leg

Intervention

Procedure:
• Delayed sclerotherapy
See arm descriptions
• Immediate phlebectomy
See arm description

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

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	Need for sclerotherapy	Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment.	3 months
Secondary	Patient satisfaction	Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL.	3 months
Secondary	Occlusion rate of great saphenous vein	Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.	36 months