Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Study Overview
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Brief Summary
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The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.

Official Title
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Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial

Conditions
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Varicose Ulcer, Varicose Veins of Lower Limb, Saphenous Vein Injury

Intervention / Treatment
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* Procedure: Radiofrequency ablation
* Procedure: Multilayer Compressive Bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years old venous ulcer appeared at least 4 weeks, bellow knee ankle-brachial index more than 0.9 saphenous veins insufficiency plus perforating veins reflux saphenous vein diameter between 5 mm and 12 mm absence of saphenous veins thrombophlebitis absence of personal history of venous deep thrombosis absence of ultrasound evidence of actual or previous venous deep thrombosis absence of severe ankle anquilosis Exclusion Criteria: Unable to provide informed consent Unable to receive surgical intervention due to severe clinical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency treatment<br>Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)<br>Procedure: Multilayer Compressive Bandage<br>* Individual receive multilayer compressive bandage once a week<br>|
| Active Comparator: Multilayer Compressive Bandage only<br>Receive only compressive treatment | Procedure: Multilayer Compressive Bandage<br>* Individual receive multilayer compressive bandage once a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing - 12 w | Ulcers was already healed after 12 weeks | 12 weeks | 
| Ulcer Healing - 24 w | Ulcers was already healed after 24 weeks | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Recurrence | Ulcer recurrence rate after 1 year of follow up | 1 year | 
| Quality of life SF-36 | Increasing in individual's quality of life using SF 36 | at the begginning and up to 1 week after ulcer had healed | 
| Quality of life EQ- 5D | Increasing in individual's quality of life using EQ-5D | at the begginning and up to 1 week after ulcer had healed | 
| Quality of life VLU-Qol | Increasing in individual's quality of life using VLU-Qol | at the begginning and up to 1 week after ulcer had healed | 
| Quality of life CCVLUQ | Increasing in individual's quality of life using VLU-Qol | at the begginning and up to 1 week after ulcer had healed | 
| Health Economic Assessment | A cost-effectiveness analysis will be performed using the collected data of resources used in participants care along the study. Cost-utility (QALY) will be calculated using EQ-5d questionarie data | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment