NCT03293836

Venous Ulcer: Endovenous Radiofrequency Treatment Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Juliana Puggina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.

Conditions

• Varicose Ulcer
• Varicose Veins of Lower Limb
• Saphenous Vein Injury

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation	Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
PROCEDURE	Multilayer Compressive Bandage	Individual receive multilayer compressive bandage once a week

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-10-31
• Completion: 2018-08-31
• First posted: 2017-09-26
• Last updated: 2017-09-26

Locations

1 site across 1 country: Brazil