Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Varicose Ulcer Clinical Trial

— VUERT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293836
• Other study ID #: Vuert trial
• Secondary ID: UTN
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: September 25, 2017
• Start date: January 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2017
• Source: University of Sao Paulo
• Contact: Juliana Puggina, MD
• Phone: +5511988604601
• Email: juliana.puggina[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 31, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Unable to provide informed consent

• Unable to receive surgical intervention due to severe clinical condition

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)	Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Juliana Puggina	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer Healing - 12 w	Ulcers was already healed after 12 weeks	12 weeks
Primary	Ulcer Healing - 24 w	Ulcers was already healed after 24 weeks	24 weeks
Secondary	Ulcer Recurrence	Ulcer recurrence rate after 1 year of follow up	1 year
Secondary	Quality of life SF-36	Increasing in individual's quality of life using SF 36	at the begginning and up to 1 week after ulcer had healed
Secondary	Quality of life EQ- 5D	Increasing in individual's quality of life using EQ-5D	at the begginning and up to 1 week after ulcer had healed
Secondary	Quality of life VLU-Qol	Increasing in individual's quality of life using VLU-Qol	at the begginning and up to 1 week after ulcer had healed
Secondary	Quality of life CCVLUQ	Increasing in individual's quality of life using VLU-Qol	at the begginning and up to 1 week after ulcer had healed
Secondary	Health Economic Assessment	A cost-effectiveness analysis will be performed using the collected data of resources used in participants care along the study. Cost-utility (QALY) will be calculated using EQ-5d questionarie data	1 year