Venous Ulcer: Endovenous Radiofrequency Treatment Trial
NCT ID: NCT03293836
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2015-01-01
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Radiofrequency treatment
Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
Radiofrequency ablation
Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
Multilayer Compressive Bandage
Individual receive multilayer compressive bandage once a week
Multilayer Compressive Bandage only
Receive only compressive treatment
Multilayer Compressive Bandage
Individual receive multilayer compressive bandage once a week
Interventions
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Radiofrequency ablation
Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
Multilayer Compressive Bandage
Individual receive multilayer compressive bandage once a week
Eligibility Criteria
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Inclusion Criteria
* venous ulcer appeared at least 4 weeks, bellow knee
* ankle-brachial index more than 0.9
* saphenous veins insufficiency plus perforating veins reflux
* saphenous vein diameter between 5 mm and 12 mm
* absence of saphenous veins thrombophlebitis
* absence of personal history of venous deep thrombosis
* absence of ultrasound evidence of actual or previous venous deep thrombosis
* absence of severe ankle anquilosis
Exclusion Criteria
* Unable to receive surgical intervention due to severe clinical condition
18 Years
80 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Juliana Puggina
OTHER
Responsible Party
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Juliana Puggina
MD
Principal Investigators
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Igor R Sincos, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Juliana Puggina, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Puggina J, Sincos IR, Campos W Jr, Porta RMP, Dos Santos JB, De Luccia N, Puech-Leao P, Collares FB, da Silva ES. A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial). Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14.
Other Identifiers
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UTN
Identifier Type: OTHER
Identifier Source: secondary_id
Vuert trial
Identifier Type: -
Identifier Source: org_study_id