TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.

Detailed Description
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Venous ulcer due to venous insufficiency causes an important morbidity to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in Spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 12 months to several years. Therapeutic alternatives, which can guarantee optimal, fast and persistent in time healing, should be identified. The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following Endovascular Laser Treatment (EVLT) of axial vein hypertension plus ultrasound-guided foam sclerotherapy of superficial venous reflux under knee, closing perforator veins and terminal reflux under de ulcer in patients with chronic venous ulceration (TAPIRS technique) plus compression with an adjustable compression system (juxta cures) versus a control group using the traditional multilayer bandages. The investigators expect that the minimal surgical invasive approach closing all the superficial venous reflux plus adjustable compression system will diminish the time of ulcer healing compared with standard treatment of multilayer bandage care.

Official Title
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Clinical Trial : Terminal Axial Perforator Interruption Reflux Source (TAPIRS ) Plus Adjustable Compression System in Treatment of Venous Leg Ulcers Versus Multilayer Bandage Treatment

Conditions
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Venous Ulcer

Intervention / Treatment
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* Other: TAPIRS
* Other: CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg Exclusion Criteria: Severe hepatic disease Severe cardiac disease Severe pulmonary disease Deep venous thrombosis Active participation in other clinical trials limitation in the ankle movements others limitations to move their self

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: tapirs<br>this group will have surgery with endovascular laser treatment (EVLT) in the axial vein and foam sclerotherapy echo-guided in perforator veins and veins in relation with the ulcer, after the surgery the patients will have conventional wound care plus juxta cure system that give a continuous compression in the leg. | Other: TAPIRS<br>* Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system<br>|
| Active Comparator: multilayer bandage<br>multilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard | Other: CONTROL<br>* Multilayer bandages and wound care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing rates | determine healing rates between two groups | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous ulcer, vein, juxta cures, foam, laser