Finnish Venous Ulcer Study (FINNULCER Study)

March 3, 2021 updated by: Toni Pihlaja, Oulu University Hospital

Finnish Venous Ulcer Study

This multicenter randomized controlled trial compares immediate foam sclerotherapy vs. scheduled endovenous treatment in patients with venous ulceration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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).

For the primary outcome the follow-up time is one year. In both groups endothermal ablation and/or foam sclerotherapy are used to treat the ulcer-related insufficient veins and truncal insufficiency. Class 2 thigh-high compression, or best possible compression therapy patient tolerates is facilitated in both groups

Study Type

Interventional

Enrollment (Anticipated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
      • Lahti, Finland
      • Oulu, Finland
      • Pori, Finland
      • Tampere, Finland
        • Not yet recruiting
        • Tampere University Hospital
        • Contact:
      • Turku, Finland
      • Vaasa, Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate foam sclerotherapy
Immediate foam sclerotherapy group patients are treated with immediate (first-visit) foam sclerotherapy and truncal vein endothermal ablation is scheduled when anatomy is suitable. Compression therapy is started 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
Scheduled treatment group patients are treated with scheduled endovenous ablation including foam sclerotherapy and/or endothermal ablation depending on reflux anatomy. Compression therapy is started 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
Time Frame: 0-365 days
Complete re-epithelialisation of ulcer area
0-365 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2021

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

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 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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