Immediate Versus Early Endovenous Ablation In Venous Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2023-08-30

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.

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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.

Conditions

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Venous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Intervention

Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).

Group Type EXPERIMENTAL

Foam sclerotherapy

Intervention Type PROCEDURE

Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.

Endothermal ablation

Intervention Type PROCEDURE

Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Early Intervention

Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).

Group Type ACTIVE_COMPARATOR

Foam sclerotherapy

Intervention Type PROCEDURE

Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.

Endothermal ablation

Intervention Type PROCEDURE

Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Interventions

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Foam sclerotherapy

Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.

Intervention Type PROCEDURE

Endothermal ablation

Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.

Intervention Type PROCEDURE

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)