RecruitingNot ApplicableNCT04737941
Finnish Venous Ulcer Study (FINNULCER Study)
Finnish Venous Ulcer Study
Sponsor
Oulu University Hospital
Enrollment
248 participants
Start Date
Feb 26, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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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Interventions
PROCEDUREEndothermal Ablation
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
PROCEDUREFoam Sclerotherapy
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT04737941
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