Immediate Versus Early Endovenous Ablation In Venous Ulcer

Not Applicable

Completed

• Conditions: Venous Ulcer
• Interventions: Procedure: Foam sclerotherapy; Procedure: Endothermal ablation

• Registration Number: NCT03795064
• Lead Sponsor: Oulu University Hospital

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 Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Primary Completion: 2023-01-30
• Study Completion: 2023-08-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention	Endothermal ablation	Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
Early Intervention	Foam sclerotherapy	Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
Immediate Intervention	Endothermal ablation	Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
Immediate Intervention	Foam sclerotherapy	Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).

Primary Outcome Measures

Name	Time	Method
Venous ulcer area	0 to 180 days	Venous ulcer area measured from calibrated digital photograph.

Secondary Outcome Measures

Name	Time	Method
Time to ulcer healing	0 to 360 days	Complete re-epithelialisation of ulcer area.
Total time of active venous ulcer	0 to 360 days	Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.

Trial Locations

Locations (1)

Oulu University Hospital, Vascular Department; 🇫🇮 Oulu, Finland