Status:
RECRUITING
Finnish Venous Ulcer Study (FINNULCER Study)
Lead Sponsor:
Oulu University Hospital
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04737941
Start Date
February 26 2021
End Date
March 1 2026
Last Update
January 15 2025
Active Locations (5)
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1
Helsinki University Central Hospital
Helsinki, Finland
2
Keski-Suomen keskussairaala
Jyväskylä, Finland
3
Oulu University Hospital
Oulu, Finland
4
Turku University Hospital
Turku, Finland