EVLA and Optimal Timing of Sclerotherapy

NCT ID: NCT04774939

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2030-03-15

Brief Summary

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The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Detailed Description

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The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Conditions

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Venous Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EVLA only

Only main trunk/trunks with venous reflux will be treated

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation

Intervention Type PROCEDURE

The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

EVLA and sclerotherapy of tributaries

Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation

Intervention Type PROCEDURE

The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

Interventions

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Endovenous laser ablation

The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

Intervention Type PROCEDURE

Other Intervention Names

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Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries

Eligibility Criteria

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Inclusion Criteria

* Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion Criteria

* No severe comorbidities. Previous DVT.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

Päijänne Tavastia Central Hospital

OTHER

Sponsor Role collaborator

Satasairaala

OTHER

Sponsor Role collaborator

Vaasa Central Hospital, Vaasa, Finland

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Khalil Firoozi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harri Hakovirta, Professor

Role: STUDY_CHAIR

University of Turku

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Central Contacts

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Harri Hakovirta, Professor

Role: CONTACT

+358405918811

Khalil Firoozi, MD

Role: CONTACT

+35823130000

Facility Contacts

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Harri Hakovirta, Professor

Role: primary

+35823130000

Khalil Firoozi, MD

Role: backup

+35823130000

References

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Viljamaa J, Firoozi K, Venermo M, Pokela M, Pihlaja T, Halmesmaki K, Hakovirta H. A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study. PLoS One. 2023 May 23;18(5):e0285823. doi: 10.1371/journal.pone.0285823. eCollection 2023.

Reference Type DERIVED
PMID: 37220130 (View on PubMed)

Other Identifiers

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93 /1801/2020

Identifier Type: -

Identifier Source: org_study_id

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