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Compression And Functional Ability After Endovenous Varicose Vein Treatment

Primary Purpose

Varicose Veins of Lower Limb, Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Class II compression stockings
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oulu University Hospital, Vascular Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No Compression

Compression

Arm Description

Patients in this group will not receive any compression after treatment

Patients in this group will use class II compression stockings continuously until next evening and then next 4 days during daytime.

Outcomes

Primary Outcome Measures

Post-operative pain
Visual Analog Scale (VAS) 0-100mm

Secondary Outcome Measures

Functional ability, other than pain
Visual Analog Scale 0-100mm indicating post-operative functional ability reduction
Aberdeen Varicose Veins Questionnaire (AVVQ)
Score from 0 to 99.658
Visual appearance of varicose veins, patient assessment
Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)
Signs of deep venous thrombosis hematoma
Ultrasound assessment
Time required returning to normal activity
Time required returning to full activity
Postoperative pigmentation
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.
Visual appearance of varicose veins, expert assessment
Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).

Full Information

First Posted
May 27, 2018
Last Updated
January 18, 2021
Sponsor
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03613376
Brief Title
Compression And Functional Ability After Endovenous Varicose Vein Treatment
Official Title
Compression And Functional Ability After Endovenous Varicose Vein Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb, Varicose Veins
Keywords
Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Compression
Arm Type
No Intervention
Arm Description
Patients in this group will not receive any compression after treatment
Arm Title
Compression
Arm Type
Active Comparator
Arm Description
Patients in this group will use class II compression stockings continuously until next evening and then next 4 days during daytime.
Intervention Type
Other
Intervention Name(s)
Class II compression stockings
Intervention Description
Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Visual Analog Scale (VAS) 0-100mm
Time Frame
10days recorded daily
Secondary Outcome Measure Information:
Title
Functional ability, other than pain
Description
Visual Analog Scale 0-100mm indicating post-operative functional ability reduction
Time Frame
10 days recorded daily
Title
Aberdeen Varicose Veins Questionnaire (AVVQ)
Description
Score from 0 to 99.658
Time Frame
Assessed preoperatively and at 2 months
Title
Visual appearance of varicose veins, patient assessment
Description
Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)
Time Frame
Preoperatively and at 2 months
Title
Signs of deep venous thrombosis hematoma
Description
Ultrasound assessment
Time Frame
Assessed at 2 months and earlier if necessary
Title
Time required returning to normal activity
Time Frame
14 days
Title
Time required returning to full activity
Time Frame
14 days
Title
Postoperative pigmentation
Description
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.
Time Frame
at 2 months
Title
Visual appearance of varicose veins, expert assessment
Description
Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).
Time Frame
Preoperatively and at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Oulu University Hospital, Vascular Department
City
Oulu
ZIP/Postal Code
90220
Country
Finland

12. IPD Sharing Statement

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Compression And Functional Ability After Endovenous Varicose Vein Treatment

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