NCT04737941

Brief Summary

This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

4 years

First QC Date

January 30, 2021

Last Update Submit

January 13, 2025

Conditions

Venous Leg Ulcer

Keywords

Venous Leg UlcerFoam SclerotherapyEndothermal AblationSub-ulcer Foam Sclerotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to ulcer Healing

    Complete re-epithelialisation of ulcer area

    0-365 days

Secondary Outcomes (3)

  • EQ-5D Questionnaire

    0-365 days

  • Wound-QOL Questionnaire

    0-365 days

  • Venous ulcer area

    0-365 days

Study Arms (2)

First-visit foam sclerotherapy

EXPERIMENTAL

Patients in the first-visit foam sclerotherapy group undergo first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy), and truncal vein endothermal ablation is scheduled when the anatomy is suitable. Compression therapy is initiated immediately.

Procedure: Endothermal AblationProcedure: Foam Sclerotherapy

Scheduled treatment

ACTIVE COMPARATOR

Patients in the scheduled treatment group receive scheduled endovenous ablation, including foam sclerotherapy and/or endothermal ablation, depending on reflux anatomy. This group represents the current standard of care. Compression therapy is initiated immediately.

Procedure: Endothermal AblationProcedure: Foam Sclerotherapy

Interventions

Endothermal AblationPROCEDURE

Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)

First-visit foam sclerotherapyScheduled treatment
Foam SclerotherapyPROCEDURE

Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.

First-visit foam sclerotherapyScheduled treatment

Eligibility Criteria

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

You may qualify if:

  • Patient informed consent
  • Venous ulcer, aged from one month to one year
  • Duplex ultrasonography verified (vein reflux greater than \>0.5 second) superficial venous insufficiency
  • Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index \> 0,8 / Toe pressure \>60mmhg)

You may not qualify if:

  • Leg ulcers other than venous etiology
  • Ulcers requiring operation theater revision
  • Patent foramen ovale
  • Several times recurrent (over 3 recurrences) venous ulcer
  • Body Mass Index over 40
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Keski-Suomen keskussairaala

Jyväskylä, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Vaasa Central Hospital

Vaasa, Finland

RECRUITING

Related Publications (2)

  • Pihlaja T, Torro P, Ohtonen P, Romsi P, Pokela M. Ten years of experience with first-visit foam sclerotherapy to initiate venous ulcer healing. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):954-960. doi: 10.1016/j.jvsv.2020.11.012. Epub 2020 Nov 25.

    PMID: 33248300BACKGROUND

  • Pihlaja T, Ohtonen P, Hakovirta H, Viljamaa J, Kukkonen T, Venermo M, Halmesmaki K, Pokela M. Trial protocol for evaluating sub-ulcer foam sclerotherapy as an adjunct to conventional endovenous treatment in patients with venous leg ulcers: The FINNULCER multicenter randomized controlled trial. Phlebology. 2025 Oct;40(9):713-718. doi: 10.1177/02683555251335618. Epub 2025 Apr 17.

    PMID: 40243046DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toni Pihlaja, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Karoliina Halmesmaki, Docent

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

  • Maarit Venermo, Professor

    Helsinki University Central Hospital

    STUDY CHAIR

  • Matti Pokela, Docent

    Oulu University Hospital

    STUDY CHAIR

Central Study Contacts

Matti Pokela, Docent

CONTACT

083152011matti.pokela@ppshp.fi

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
Principal Investigator

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

February 26, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

FI(5)