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Clinical Trials/NCT02798445
NCT02798445
Unknown
Not Applicable

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 sites26 target enrollmentJune 2016
ConditionsVenous Ulcer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Ulcer
Sponsor
Hospital Occidente de Kennedy
Enrollment
26
Primary Endpoint
healing rates
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Occidente de Kennedy
Responsible Party
Principal Investigator
Principal Investigator

ernesto nieves

vascular surgeon, md.

Hospital Occidente de Kennedy

Eligibility Criteria

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

Outcomes

Primary Outcomes

healing rates

Time Frame: 12 weeks

determine healing rates between two groups

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