Immediate Versus Early Endovenous Ablation In Venous Ulcer

Study Overview
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Brief Summary
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The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

Detailed Description
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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.

Official Title
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Immediate Versus Early Endovenous Ablation In Venous Ulcer

Conditions
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Venous Ulcer

Intervention / Treatment
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* Procedure: Foam sclerotherapy
* Procedure: Endothermal ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention). | Procedure: Foam sclerotherapy<br>* Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.<br>Procedure: Endothermal ablation<br>* Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.<br>|
| Active Comparator: Early Intervention<br>Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention). | Procedure: Foam sclerotherapy<br>* Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.<br>Procedure: Endothermal ablation<br>* Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous ulcer area | Venous ulcer area measured from calibrated digital photograph. | 0 to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ulcer healing | Complete re-epithelialisation of ulcer area. | 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. | 0 to 360 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins