Immediate Versus Early Endovenous Ablation In Venous Ulcer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oulu University Hospital
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Venous ulcer area
Study Overview
Brief Summary
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Venous ulcer > 1 month
- •Ulcer area > 1cm2
- •Palpable distal pulses / Ankle-brachial index > 0,8 / Toe-brachial index > 70mmhg (at least one criteria must be met)
Exclusion Criteria
- •Leg ulcers other than venous etiology
- •Pregnancy
- •General contraindications for foam sclerotherapy
- •Ulcers requiring operation theater revision
Outcomes
Primary Outcomes
Venous ulcer area
Time Frame: 0 to 180 days
Venous ulcer area measured from calibrated digital photograph.
Secondary Outcomes
- Time to ulcer healing(0 to 360 days)
- Total time of active venous ulcer(0 to 360 days)
Investigators
Toni Pihlaja
Vascular Specialist
Oulu University Hospital