Venous Ulcer Clinical Trial
Official title:
Clinical Trial : Terminal Axial Perforator Interruption Reflux Source (TAPIRS ) Plus Adjustable Compression System in Treatment of Venous Leg Ulcers Versus Multilayer Bandage Treatment
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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