Finnish Venous Ulcer Study
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Keski-Suomen keskussairaala
RECRUITING
Jyväskylä
Oulu University Hospital
RECRUITING
Oulu
Turku University Hospital
RECRUITING
Turku
Vaasa Central Hospital
RECRUITING
Vaasa
Contact Information
Primary
Matti Pokela, Docent
matti.pokela@ppshp.fi
083152011
Time Frame
Start Date: 2021-02-26
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 248
Treatments
Experimental: First-visit foam sclerotherapy
Patients in the first-visit foam sclerotherapy group undergo first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy), and truncal vein endothermal ablation is scheduled when the anatomy is suitable. Compression therapy is initiated immediately.
Active_comparator: Scheduled treatment
Patients in the scheduled treatment group receive scheduled endovenous ablation, including foam sclerotherapy and/or endothermal ablation, depending on reflux anatomy. This group represents the current standard of care. Compression therapy is initiated immediately.
Related Therapeutic Areas
Sponsors
Collaborators: Helsinki University Central Hospital
Leads: Oulu University Hospital