Venous Ulcer: Endovenous Radiofrequency Treatment Trial (VUERT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Varicose Ulcer; Varicose Veins of Lower Limb; Saphenous Vein Injury
• Intervention / Treatment: Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana Puggina, MD; Phone Number: +5511988604601; Email: juliana.puggina@usp.br
• Study Contact Backup: Name: Igor R Sincos, PhD; Phone Number: +5511984477382; Email: igorsincos@usp.br

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 05403-010
      • Recruiting
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
      • Contact: Juliana Puggina, MD; Phone Number: +5511988604601; Email: juliana.puggina@usp.br
      • Contact: Debora Nolli; Phone Number: +5511999707101; Email: vuert.trial@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency treatment; Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment	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
Active Comparator: Multilayer Compressive Bandage only; Receive only compressive treatment	Procedure: Multilayer Compressive Bandage; Individual receive multilayer compressive bandage once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer Healing - 12 w	Ulcers was already healed after 12 weeks	12 weeks
Ulcer Healing - 24 w	Ulcers was already healed after 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer Recurrence	Ulcer recurrence rate after 1 year of follow up	1 year
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Juliana Puggina
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Igor R Sincos, PhD, University of Sao Paulo; Principal Investigator: Juliana Puggina, MD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): October 31, 2017
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; Venous ulcer; Varicose ulcer; Perforating veins insufficiency; Varicose veins treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Ulcer; Varicose Ulcer; Varicose Veins
• Other Study ID Numbers: Vuert trial; UTN (Other Identifier: U1111-1194-4910)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No