The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
Oulu University Hospital, Vascular Department
Oulu, Finland
Venous ulcer area
Venous ulcer area measured from calibrated digital photograph.
Time frame: 0 to 180 days
Time to ulcer healing
Complete re-epithelialisation of ulcer area.
Time frame: 0 to 360 days
Total time of active venous ulcer
Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
Time frame: 0 to 360 days
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