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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02798445
Study type Interventional
Source Hospital Occidente de Kennedy
Contact ernesto nieves, md
Phone 573108800230
Email ernestonieves1@hotmail.com
Status Not yet recruiting
Phase N/A
Start date June 2016
Completion date June 2017

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