NCT03613376

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

May 27, 2018

Last Update Submit

January 18, 2021

Conditions

Varicose Veins of Lower LimbVaricose Veins

Keywords

Varicose veinsCompression stockingsSclerotherapyRadiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Visual Analog Scale (VAS) 0-100mm

    10days recorded daily

Secondary Outcomes (8)

  • Functional ability, other than pain

    10 days recorded daily

  • Aberdeen Varicose Veins Questionnaire (AVVQ)

    Assessed preoperatively and at 2 months

  • Visual appearance of varicose veins, patient assessment

    Preoperatively and at 2 months

  • Signs of deep venous thrombosis hematoma

    Assessed at 2 months and earlier if necessary

  • Time required returning to normal activity

    14 days

  • +3 more secondary outcomes

Study Arms (2)

No Compression

NO INTERVENTION

Patients in this group will not receive any compression after treatment

Compression

ACTIVE COMPARATOR

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

Interventions

Class II compression stockingsOTHER

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

Compression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital, Vascular Department

Oulu, 90220, Finland

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular specialist

Study Record Dates

First Submitted

May 27, 2018

First Posted

August 3, 2018

Study Start

May 21, 2018

Primary Completion

December 21, 2020

Study Completion

January 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

FI(1)