Delayed or Immediate Local Treatment of Veins (DELICATVE)

August 8, 2022 updated by: Maarit Venermo, Helsinki University Central Hospital

Delayed or Immediate Local Treatment of Varicose Veins

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Occlusion rate of great saphenous vein
Time Frame: 36 months
Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Karoliina Halmesmäki, M.D., Ph.D, Helsinki University Central Hospital
  • Study Director: Maarit Venermo, M.D., Ph.D., Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2016

Primary Completion (Actual)

December 20, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELICATVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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