Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

March 29, 2019 updated by: Toni Pihlaja, Oulu University Hospital
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.

Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.

Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Study Type

Interventional

Enrollment (Anticipated)

200

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
    • Pohjois-Pohjanmaa
      • Raahe, Pohjois-Pohjanmaa, Finland, 92101
        • Raahe's 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation

Exclusion Criteria:

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Patient unwilling to participate

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 compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
Device: Class II Compression Stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Truncal vein occlusion rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain assessed with visual analogue scale (VAS)
Time Frame: 10 days
10 days
Painkillers usage after treatment
Time Frame: 10 days
Need for Paracetamol/NSAIDs after treatment
10 days
Aberdeen Varicose Veins Questionnaire (AVVQ)
Time Frame: 6 months
Assessed preoperatively and at one and six months
6 months
Compliance with compression stockings
Time Frame: 7 days
To assess compliance and possible reasons for non-compliance at compression group
7 days
Time required returning to normal work and activity level
Time Frame: 14 days
14 days
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
Time Frame: 30days
Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).
30days

Collaborators and Investigators

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

Sponsor

Oulu University Hospital

Investigators

  • Principal Investigator: Toni Pihlaja, M.D., Oulu University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131/2016

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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