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Finnish Venous Ulcer Study (FINNULCER Study)

Primary Purpose

Venous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Endothermal Ablation
Foam Sclerotherapy
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring Venous ulcer, Foam sclerotherapy, Endothermal ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • Paijat-Hame Central Hospital
  • Oulu University HospitalRecruiting
  • Satakunta Central HospitalRecruiting
  • Tampere University Hospital
  • Turku University HospitalRecruiting
  • Vaasa Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate foam sclerotherapy

Scheduled treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to ulcer Healing
Complete re-epithelialisation of ulcer area

Secondary Outcome Measures

EQ-5D Questionnaire
Score 0-100 where higher is better
Wound-QOL Questionnaire
Score 0-17 where lower is better
Venous ulcer area
Reduction on venous ulcer maximum diameter

Full Information

First Posted
January 30, 2021
Last Updated
March 3, 2021
Sponsor
Oulu University Hospital
Collaborators
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04737941
Brief Title
Finnish Venous Ulcer Study (FINNULCER Study)
Official Title
Finnish Venous Ulcer Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
Collaborators
Helsinki University Central Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer
Keywords
Venous ulcer, Foam sclerotherapy, Endothermal ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate foam sclerotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Scheduled treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endothermal Ablation
Intervention Description
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
Intervention Type
Procedure
Intervention Name(s)
Foam Sclerotherapy
Intervention Description
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
Primary Outcome Measure Information:
Title
Time to ulcer Healing
Description
Complete re-epithelialisation of ulcer area
Time Frame
0-365 days
Secondary Outcome Measure Information:
Title
EQ-5D Questionnaire
Description
Score 0-100 where higher is better
Time Frame
0-365 days
Title
Wound-QOL Questionnaire
Description
Score 0-17 where lower is better
Time Frame
0-365 days
Title
Venous ulcer area
Description
Reduction on venous ulcer maximum diameter
Time Frame
0-365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matti Pokela, Docent
Phone
083152011
Ext
+315
Email
matti.pokela@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Pihlaja, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karoliina Halmesmaki, Docent
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maarit Venermo, Professor
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matti Pokela, Docent
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karoliina Halmesmaki, Docent
Email
karoliina.halmesmaki@hus.fi
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommi Auvinen, MD
Email
tommi.auvinen@kuh.fi
Facility Name
Paijat-Hame Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sari Vähäaho
Email
sari.vahaaho@phhyky.fi
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matti Pokela, Docent
Email
matti.pokela@ppshp.fi
Facility Name
Satakunta Central Hospital
City
Pori
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harri Hakovirta, Professor
Email
harri.hakovirta@tyks.fi
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jukka Saarinen, Docent
Email
jukka.saarinen@pshp.fi
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harri Hakovirta, Professor
Email
harri.hakovirta@tyks.fi
Facility Name
Vaasa Central Hospital
City
Vaasa
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesa Rajala, MD
Email
vesa.rajala@vshp.fi

12. IPD Sharing Statement

Citations:
PubMed Identifier
33248300
Citation
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.
Results Reference
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Finnish Venous Ulcer Study (FINNULCER Study)

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