Compression And Functional Ability After Endovenous Varicose Vein Treatment

January 18, 2021 updated by: Toni Pihlaja, Oulu University Hospital
Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

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
      • Oulu, Finland, 90220
        • Oulu University Hospital, Vascular Department

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Distal varicose vein insufficiency suitable for sclerotherapy
  • Patient willingness to participate

Exclusion Criteria:

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Antithrombotic medication (ASA accepted)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Compression
Patients in this group will not receive any compression after treatment
Active Comparator: Compression
Patients in this group will use class II compression stockings continuously until next evening and then next 4 days during daytime.
Other: Class II compression stockings
Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 10days recorded daily
Visual Analog Scale (VAS) 0-100mm
10days recorded daily

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ability, other than pain
Time Frame: 10 days recorded daily
Visual Analog Scale 0-100mm indicating post-operative functional ability reduction
10 days recorded daily
Aberdeen Varicose Veins Questionnaire (AVVQ)
Time Frame: Assessed preoperatively and at 2 months
Score from 0 to 99.658
Assessed preoperatively and at 2 months
Visual appearance of varicose veins, patient assessment
Time Frame: Preoperatively and at 2 months
Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)
Preoperatively and at 2 months
Signs of deep venous thrombosis hematoma
Time Frame: Assessed at 2 months and earlier if necessary
Ultrasound assessment
Assessed at 2 months and earlier if necessary
Time required returning to normal activity
Time Frame: 14 days
14 days
Time required returning to full activity
Time Frame: 14 days
14 days
Postoperative pigmentation
Time Frame: at 2 months
Pigmentation is monitored from standardised photographs on severity of pigmentation and most severe tone of post-operative pigmentation compared to base skin colour, reviewers are blinded to study group.
at 2 months
Visual appearance of varicose veins, expert assessment
Time Frame: Preoperatively and at 2 months
Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).
Preoperatively and at 2 months

Collaborators and Investigators

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

Sponsor

Oulu University 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 21, 2018

Primary Completion (Actual)

December 21, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

May 27, 2018

First Submitted That Met QC Criteria

July 29, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97/2018

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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