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Finnish Venous Ulcer Study (FINNULCER Study)

Launched by OULU UNIVERSITY HOSPITAL · Jan 30, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Venous Leg Ulcer Foam Sclerotherapy Endothermal Ablation Sub Ulcer Foam Sclerotherapy

ClinConnect Summary

The Finnish Venous Ulcer Study (FINNULCER Study) is a clinical trial looking to compare two different treatments for people suffering from venous ulcers, which are painful sores on the legs caused by poor blood flow in the veins. In this study, some participants will receive immediate foam sclerotherapy, a treatment that involves injecting a foam solution into the veins to help them close off and improve blood flow. Others will receive a scheduled endovenous treatment, which is a different method done at a later time. The goal is to find out which approach works better for healing these ulcers.

To participate in this study, individuals should be aged between 65 and 74 years and must have a venous ulcer that has been present for at least one month but less than a year. They also need to have certain blood flow conditions verified by a specific ultrasound test. However, not everyone will be eligible: people with other types of leg ulcers, those who have had multiple ulcers before, or those who are pregnant, among other criteria, cannot join. Participants can expect to receive one of the two treatments and will be monitored closely throughout the study to assess how well each treatment works. This research is important as it aims to improve care and healing for individuals suffering from venous ulcers.

Gender

ALL

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

About Oulu University Hospital

Oulu University Hospital is a leading academic medical center located in Oulu, Finland, dedicated to advancing healthcare through innovative clinical research and education. As a sponsor of clinical trials, the hospital leverages its robust infrastructure, interdisciplinary expertise, and commitment to patient-centered care to facilitate groundbreaking studies across various medical disciplines. By fostering collaboration between researchers, healthcare professionals, and patients, Oulu University Hospital aims to translate scientific discoveries into effective treatments and improve health outcomes, contributing to the global advancement of medical knowledge.

Locations

Helsinki, , Finland

Oulu, , Finland

Kuopio, , Finland

Tampere, , Finland

Turku, , Finland

Vaasa, , Finland

Lahti, , Finland

Pori, , Finland

Jyväskylä, , Finland

Patients applied

0 patients applied

Trial Officials

Toni Pihlaja, MD

Principal Investigator

Oulu University Hospital

Karoliina Halmesmaki, Docent

Principal Investigator

Helsinki University Central Hospital

Maarit Venermo, Professor

Study Chair

Helsinki University Central Hospital

Matti Pokela, Docent

Study Chair

Oulu University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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