Delayed or Immediate Local Treatment of Veins (DELICATVE)
Primary Purpose
Varicose Veins Leg
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Delayed sclerotherapy
Immediate phlebectomy
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins Leg focused on measuring Varicose veins, phlebectomy
Eligibility Criteria
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
Sites / Locations
- Helsinki University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immediate phlebectomy
Delayed treatment
Arm Description
Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Occlusion rate of great saphenous vein
Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
Full Information
NCT ID
NCT03340246
First Posted
October 13, 2017
Last Updated
August 8, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03340246
Brief Title
Delayed or Immediate Local Treatment of Veins
Acronym
DELICATVE
Official Title
Delayed or Immediate Local Treatment of Varicose Veins
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2016 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins Leg
Keywords
Varicose veins, phlebectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate phlebectomy
Arm Type
Active Comparator
Arm Description
Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
Intervention Type
Procedure
Intervention Name(s)
Delayed sclerotherapy
Intervention Description
See arm descriptions
Intervention Type
Procedure
Intervention Name(s)
Immediate phlebectomy
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Need for sclerotherapy
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
3 months
Title
Occlusion rate of great saphenous vein
Description
Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karoliina Halmesmäki, M.D., Ph.D
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maarit Venermo, M.D., Ph.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Delayed or Immediate Local Treatment of Veins
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