Delayed or Immediate Local Treatment of Veins (DELICATVE)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03340246|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins Leg||Procedure: Delayed sclerotherapy Procedure: Immediate phlebectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Delayed or Immediate Local Treatment of Varicose Veins|
|Actual Study Start Date :||May 4, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Immediate phlebectomy
Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Procedure: Immediate phlebectomy
See arm description
Experimental: Delayed treatment
Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
Procedure: Delayed sclerotherapy
See arm descriptions
- Need for sclerotherapy [ Time Frame: 3 months ]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.
- Patient satisfaction [ Time Frame: 3 months ]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.
- Occlusion rate of great saphenous vein [ Time Frame: 36 months ]Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
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): NCT03340246
|Contact: Karoliina Halmesmäki, M.D., Ph.D.||+email@example.com|
|Contact: Maarit Venermo, M.D., Ph.D.||+firstname.lastname@example.org|
|Helsinki University Hospital||Recruiting|
|Helsinki, Finland, 00029|
|Contact: Maarit Venermo, Professor +358504272117 email@example.com|
|Contact: Karoliina Halmesmäki, M.D., Ph.D. firstname.lastname@example.org|
|Sub-Investigator: Sari Vähäaho, M.D.|
|Sub-Investigator: Patrick Björkman, M.D.|
|Principal Investigator:||Karoliina Halmesmäki, M.D., Ph.D||Helsinki University Central Hospital|
|Study Director:||Maarit Venermo, M.D., Ph.D.||Helsinki University Central Hospital|