Ten years of experience with first-visit foam sclerotherapy to initiate venous ulcer healing.
Toni Pihlaja, Pia Torro, Pasi Ohtonen...
https://pubmed.ncbi.nlm.nih.gov/33248300Actively Recruiting
Led by Oulu University Hospital · Updated on 2025-01-15
248
Participants Needed
5
Research Sites
261 weeks
Total Duration
O
Oulu University Hospital
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
This research aims to assess the impact of first-visit foam sclerotherapy on patients with venous leg ulcers. It compares this approach to the current standard scheduled treatment to determine which leads to faster ulcer healing. The study is based on prior data suggesting potential benefits of early foam sclerotherapy and includes patients with ulcers lasting between one month and one year. Participants are randomly assigned to either receive foam sclerotherapy at their first visit or to follow the scheduled treatment plan. Both groups also receive endothermal ablation and/or foam sclerotherapy during scheduled visits to treat problematic veins related to the ulcer. All participants use class 2 thigh-high compression stockings or the best tolerated compression therapy as part of their care. The treatments focus on insufficient truncal and distal veins. During the study, patients are monitored for up to one year to measure the time it takes for their ulcers to heal. Researchers use duplex ultrasonography to verify vein reflux and assess arterial circulation. Safety and healing progress are carefully tracked, with the primary outcome being the duration until ulcer healing. The total study plans to enroll 248 patients to ensure reliable results.
CONDITIONS
Finnish Venous Ulcer Study (FINNULCER Study)
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Total: 5 locations
1
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
2
Keski-Suomen keskussairaala
Jyväskylä, Finland
Actively Recruiting
3
Oulu University Hospital
Oulu, Finland
Actively Recruiting
4
Turku University Hospital
Turku, Finland
Actively Recruiting
5
Vaasa Central Hospital
Vaasa, Finland
Actively Recruiting
M
Matti Pokela, Docent
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Toni Pihlaja, Pia Torro, Pasi Ohtonen...
https://pubmed.ncbi.nlm.nih.gov/33248300Toni Pihlaja, Pasi Ohtonen, Harri Hakovirta...
https://pubmed.ncbi.nlm.nih.gov/40243046