Finnish Venous Ulcer Study (FINNULCER Study)
ConditionVenous Leg Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOulu University Hospital
About this trial
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
Qualifiers
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)
Disqualifiers
Leg ulcers other than venous etiology
Ulcers requiring operation theater revision
Patent foramen ovale
Several times recurrent (over 3 recurrences) venous ulcer
Trial design
Treatments tested in this trial
- Endothermal Ablation
- Foam Sclerotherapy
Treatment groups
248 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oulu University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov