Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial

• Grant number: 15/17004-4
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2016
• End date: July 31, 2018
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Igor Rafael Sincos
• Grantee: Igor Rafael Sincos
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Anna Paula Weinhardt Baptista Sincos ; Erasmo Simão da Silva ; Felipe Birchal Collares ; Jorgete Barreto dos Santos ; Juliana Puggina ; Rina Maria Pereira Porta ; Walter Campos Junior

Abstract

Venous ulcer is one of the most serious manifestations of lower limb chronic venous insufficiency and has great importance to public health, due to its high incidence and prevalence and high social and economic impact. Lower limbs elevation rest, associated with compression and exercise are simple measures that accelerate ulcer closure, however, show significant recurrence rate (26-28% in 12 months, reaching 69%). Isolated surgical treatment of superficial venous system does not provide a greater wound-healing rate than the compressive treatment, but greatly decreases the ulcer recurrence chance. The endovenous ablation therapy has not been adequately studied for the venous ulcer treatment. In a recently published systematic review, no prospective clinical randomized study was found on this kind of treatment.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 patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. They will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Wound healing and recurrence, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer's healing. (AU)