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Finnish Venous Ulcer Study (FINNULCER Study)

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ClinicalTrials.gov Identifier: NCT04737941
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Toni Pihlaja, Oulu University Hospital

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

Condition or disease Intervention/treatment Phase
Venous Ulcer Procedure: Endothermal Ablation Procedure: Foam Sclerotherapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Finnish Venous Ulcer Study
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2026

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.




Primary Outcome Measures :
  1. Time to ulcer Healing [ Time Frame: 0-365 days ]
    Complete re-epithelialisation of ulcer area


Secondary Outcome Measures :
  1. EQ-5D Questionnaire [ Time Frame: 0-365 days ]
    Score 0-100 where higher is better

  2. Wound-QOL Questionnaire [ Time Frame: 0-365 days ]
    Score 0-17 where lower is better

  3. Venous ulcer area [ Time Frame: 0-365 days ]
    Reduction on venous ulcer maximum diameter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737941


Contacts
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Contact: Matti Pokela, Docent 083152011 ext +315 matti.pokela@ppshp.fi

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Karoliina Halmesmaki, Docent       karoliina.halmesmaki@hus.fi   
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Tommi Auvinen, MD       tommi.auvinen@kuh.fi   
Paijat-Hame Central Hospital Not yet recruiting
Lahti, Finland
Contact: Sari Vähäaho       sari.vahaaho@phhyky.fi   
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Matti Pokela, Docent       matti.pokela@ppshp.fi   
Satakunta Central Hospital Recruiting
Pori, Finland
Contact: Harri Hakovirta, Professor       harri.hakovirta@tyks.fi   
Tampere University Hospital Not yet recruiting
Tampere, Finland
Contact: Jukka Saarinen, Docent       jukka.saarinen@pshp.fi   
Turku University Hospital Recruiting
Turku, Finland
Contact: Harri Hakovirta, Professor       harri.hakovirta@tyks.fi   
Vaasa Central Hospital Recruiting
Vaasa, Finland
Contact: Vesa Rajala, MD       vesa.rajala@vshp.fi   
Sponsors and Collaborators
Oulu University Hospital
Helsinki University Central Hospital
Investigators
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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:
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Responsible Party: Toni Pihlaja, Principal Investigator, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT04737941    
Other Study ID Numbers: 3/2021
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toni Pihlaja, Oulu University Hospital:
Venous ulcer
Foam sclerotherapy
Endothermal ablation
Additional relevant MeSH terms:
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Varicose Ulcer
Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases