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Compression And Functional Ability After Endovenous Varicose Vein Treatment

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ClinicalTrials.gov Identifier: NCT03613376
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Toni Pihlaja, Oulu University Hospital

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)

Condition or disease Intervention/treatment Phase
Varicose Veins of Lower Limb Varicose Veins Other: Class II compression stockings Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compression And Functional Ability After Endovenous Varicose Vein Treatment
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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




Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: 10days recorded daily ]
    Visual Analog Scale (VAS) 0-100mm


Secondary Outcome Measures :
  1. Functional ability, other than pain [ Time Frame: 10 days recorded daily ]
    Visual Analog Scale 0-100mm indicating post-operative functional ability reduction

  2. Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: Assessed preoperatively and at 2 months ]
    Score from 0 to 99.658

  3. 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)

  4. Signs of deep venous thrombosis hematoma [ Time Frame: Assessed at 2 months and earlier if necessary ]
    Ultrasound assessment

  5. Time required returning to normal activity [ Time Frame: 14 days ]
  6. Time required returning to full activity [ Time Frame: 14 days ]
  7. 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.

  8. 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613376


Contacts
Contact: Matti Pokela, Docent +31583152011 matti.pokela@ppshp.fi

Locations
Finland
Oulu University Hospital, Vascular Department Recruiting
Oulu, Finland, 90220
Contact: Matti Pokela, Docent    +35883152011    matti.pokela@ppshp.fi   
Principal Investigator: Toni Pihlaja, M.D.         
Sponsors and Collaborators
Oulu University Hospital

Responsible Party: Toni Pihlaja, Vascular specialist, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT03613376     History of Changes
Other Study ID Numbers: 97/2018
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Toni Pihlaja, Oulu University Hospital:
Varicose veins
Compression stockings
Sclerotherapy
Radiofrequency ablation

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases