Finnish Venous Ulcer Study (FINNULCER Study)
- Conditions
- Venous Leg Ulcer
- Interventions
- Procedure: Endothermal AblationProcedure: Foam Sclerotherapy
- Registration Number
- NCT04737941
- Lead Sponsor
- Oulu University Hospital
- 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 scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.
In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).
Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.
For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.
Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 248
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Scheduled treatment Foam Sclerotherapy Scheduled treatment group patients are treated with scheduled endovenous ablation including foam sclerotherapy and/or endothermal ablation depending on reflux anatomy. Compression therapy is started immediately. Scheduled treatment Endothermal Ablation Scheduled treatment group patients are treated with scheduled endovenous ablation including foam sclerotherapy and/or endothermal ablation depending on reflux anatomy. Compression therapy is started immediately. Immediate foam sclerotherapy Foam Sclerotherapy Immediate foam sclerotherapy group patients are treated with immediate (first-visit) foam sclerotherapy and truncal vein endothermal ablation is scheduled when anatomy is suitable. Compression therapy is started immediately. Immediate foam sclerotherapy Endothermal Ablation Immediate foam sclerotherapy group patients are treated with immediate (first-visit) foam sclerotherapy and truncal vein endothermal ablation is scheduled when anatomy is suitable. Compression therapy is started immediately.
- Primary Outcome Measures
Name Time Method Time to ulcer Healing 0-365 days Complete re-epithelialisation of ulcer area
- Secondary Outcome Measures
Name Time Method EQ-5D Questionnaire 0-365 days Score 0-100 where higher is better
Venous ulcer area 0-365 days Reduction on venous ulcer maximum diameter
Wound-QOL Questionnaire 0-365 days Score 0-17 where lower is better
Trial Locations
- Locations (5)
Oulu University Hospital
🇫🇮Oulu, Finland
Turku University Hospital
🇫🇮Turku, Finland
Keski-Suomen keskussairaala
🇫🇮Jyväskylä, Finland
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Vaasa Central Hospital
🇫🇮Vaasa, Finland