NCT03795064

Immediate Versus Early Endovenous Ablation In Venous Ulcer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
PROCEDURE	Foam sclerotherapy	Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
PROCEDURE	Endothermal ablation	Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Timeline

• Start date: 2018-12-05
• Primary completion: 2023-01-30
• Completion: 2023-08-30
• First posted: 2019-01-07
• Last updated: 2024-04-03

Locations

1 site across 1 country: Finland