Trial Parameters
Condition Venous Leg Ulcer
Sponsor Oulu University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 248
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-02-26
Completion 2025-03-01
Interventions
Endothermal AblationFoam Sclerotherapy
Brief 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 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
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