NCT02798445

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Hospital Occidente de Kennedy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
OTHER	TAPIRS	Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system
OTHER	CONTROL	Multilayer bandages and wound care

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2016-06-14
• Last updated: 2016-08-23