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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02798445
Acronym
TAPIRS
Enrollment
26
Registered
2016-06-14
Start date
2016-06-30
Completion date
2017-06-30
Last updated
2016-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcer

Keywords

venous ulcer, vein, juxta cures, foam, laser

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.

Interventions

OTHERTAPIRS

Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system

OTHERCONTROL

Multilayer bandages and wound care

Sponsors

Hospital Occidente de Kennedy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
healing rates12 weeksdetermine healing rates between two groups

Contacts

Primary Contacternesto nieves, md
ernestonieves1@hotmail.com573108800230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026