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NCT02798445 Clinical Trial

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

Venous Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02798445
Other study ID # TAPIRS
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 5, 2016
Last updated August 19, 2016
Start date June 2016
Est. completion date June 2017

Study information
Verified date August 2016
Source Hospital Occidente de Kennedy
Contact ernesto nieves, md
Phone 573108800230
Email ernestonieves1@hotmail.com
Is FDA regulated No
Health authority Colombia: Ethics Committee
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 26
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• TAPIRS
Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system
• CONTROL
Multilayer bandages and wound care

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Occidente de Kennedy

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary healing rates determine healing rates between two groups 12 weeks Yes
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