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

Primary Purpose

Venous Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAPIRS
CONTROL
Sponsored by
Hospital Occidente de Kennedy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring venous ulcer, vein, juxta cures, foam, laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    tapirs

    multilayer bandage

    Arm Description

    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.

    multilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard

    Outcomes

    Primary Outcome Measures

    healing rates
    determine healing rates between two groups

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2016
    Last Updated
    August 19, 2016
    Sponsor
    Hospital Occidente de Kennedy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02798445
    Brief Title
    TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers
    Acronym
    TAPIRS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Occidente de Kennedy

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Ulcer
    Keywords
    venous ulcer, vein, juxta cures, foam, laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tapirs
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    multilayer bandage
    Arm Type
    Active Comparator
    Arm Description
    multilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard
    Intervention Type
    Other
    Intervention Name(s)
    TAPIRS
    Intervention Description
    Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system
    Intervention Type
    Other
    Intervention Name(s)
    CONTROL
    Intervention Description
    Multilayer bandages and wound care
    Primary Outcome Measure Information:
    Title
    healing rates
    Description
    determine healing rates between two groups
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ernesto nieves, md
    Phone
    573108800230
    Email
    ernestonieves1@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20362477
    Citation
    Darvall KA, Sam RC, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Photoplethysmographic venous refilling times following ultrasound guided foam sclerotherapy for symptomatic superficial venous reflux: relationship with clinical outcomes. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):267-72. doi: 10.1016/j.ejvs.2010.02.025. Epub 2010 Apr 1.
    Results Reference
    background
    PubMed Identifier
    20875753
    Citation
    Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27.
    Results Reference
    background

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

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