Finnish Venous Ulcer Study (FINNULCER Study)

Finnish Venous Ulcer Study

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

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Procedure: Endothermal Ablation; Procedure: Foam Sclerotherapy

Detailed Description

To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.

In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).

Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.

For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.

Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matti Pokela, Docent; Phone Number: +315 083152011; Email: matti.pokela@ppshp.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Karoliina Halmesmaki, Docent; Email: karoliina.halmesmaki@hus.fi
  • Jyväskylä, Finland
    • Recruiting
    • Keski-Suomen Keskussairaala
    • Contact: Tiia Kukkonen
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Matti Pokela, Docent; Email: matti.pokela@ppshp.fi
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Harri Hakovirta, Professor; Email: harri.hakovirta@tyks.fi
  • Vaasa, Finland
    • Recruiting
    • Vaasa Central Hospital
    • Contact: Vesa Rajala, MD; Email: vesa.rajala@vshp.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First-visit foam sclerotherapy; 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 Ablation; Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein); Procedure: Foam Sclerotherapy; Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
Active Comparator: Scheduled treatment; 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 Ablation; Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein); Procedure: Foam Sclerotherapy; Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ulcer Healing	Complete re-epithelialisation of ulcer area	0-365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D Questionnaire	Score 0-100 where higher is better	0-365 days
Wound-QOL Questionnaire	Score 0-17 where lower is better	0-365 days
Venous ulcer area	Reduction on venous ulcer maximum diameter	0-365 days

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Helsinki University Central Hospital
• Investigators: Principal Investigator: Toni Pihlaja, MD, Oulu University Hospital; Principal Investigator: Karoliina Halmesmaki, Docent, Helsinki University Central Hospital; Study Chair: Maarit Venermo, Professor, Helsinki University Central Hospital; Study Chair: Matti Pokela, Docent, Oulu University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Venous Leg Ulcer; Endothermal Ablation; Foam Sclerotherapy; Sub-ulcer Foam Sclerotherapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: 3/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No