Status:
UNKNOWN
Venous Ulcer: Endovenous Radiofrequency Treatment Trial
Lead Sponsor:
Juliana Puggina
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Varicose Ulcer
Varicose Veins of Lower Limb
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in pat...
Eligibility Criteria
Inclusion
- age between 18 and 80 years old
- 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
- Unable to provide informed consent
- Unable to receive surgical intervention due to severe clinical condition
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03293836
Start Date
January 1 2015
End Date
August 31 2018
Last Update
September 26 2017
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
São Paulo, São Paulo, Brazil, 05403-010