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临床试验/NCT02798445
NCT02798445Unknown不适用

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

Hospital Occidente de Kennedy0 个研究点目标入组 26 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
26
主要终点
healing rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg

排除标准

  • 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

结局指标

主要结局

healing rates

时间窗: 12 weeks

determine healing rates between two groups

次要结局

未报告次要终点

研究者

发起方
Hospital Occidente de Kennedy
申办方类型
Other
责任方
Principal Investigator
主要研究者

ernesto nieves

vascular surgeon, md.

Hospital Occidente de Kennedy

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