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Venous Ulcer: Endovenous Radiofrequency Treatment Trial (VUERT)

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Radiofrequency ablation

Multilayer Compressive Bandage

About this trial

This is an interventional treatment trial for Varicose Ulcer focused on measuring Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiofrequency treatment

Multilayer Compressive Bandage only

Arm Description

Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment

Receive only compressive treatment

Outcomes

Primary Outcome Measures

Ulcer Healing - 12 w

Ulcers was already healed after 12 weeks

Ulcer Healing - 24 w

Ulcers was already healed after 24 weeks

Secondary Outcome Measures

Ulcer Recurrence

Ulcer recurrence rate after 1 year of follow up

Quality of life SF-36

Increasing in individual's quality of life using SF 36

Quality of life EQ- 5D

Increasing in individual's quality of life using EQ-5D

Quality of life VLU-Qol

Increasing in individual's quality of life using VLU-Qol

Quality of life CCVLUQ

Increasing in individual's quality of life using VLU-Qol

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

Full Information

NCT ID

NCT03293836

First Posted

March 20, 2017

Last Updated

September 25, 2017

Sponsor

Juliana Puggina

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03293836

Brief Title

Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Acronym

VUERT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

October 31, 2017 (Anticipated)

Study Completion Date

August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Juliana Puggina

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency treatment

Arm Type

Experimental

Arm Description

Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment

Arm Title

Multilayer Compressive Bandage only

Arm Type

Active Comparator

Arm Description

Receive only compressive treatment

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation

Intervention Description

Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)

Intervention Type

Procedure

Intervention Name(s)

Multilayer Compressive Bandage

Intervention Description

Individual receive multilayer compressive bandage once a week

Primary Outcome Measure Information:

Title

Ulcer Healing - 12 w

Description

Ulcers was already healed after 12 weeks

Time Frame

12 weeks

Title

Ulcer Healing - 24 w

Description

Ulcers was already healed after 24 weeks

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Ulcer Recurrence

Description

Ulcer recurrence rate after 1 year of follow up

Time Frame

1 year

Title

Quality of life SF-36

Description

Increasing in individual's quality of life using SF 36

Time Frame

at the begginning and up to 1 week after ulcer had healed

Title

Quality of life EQ- 5D

Description

Increasing in individual's quality of life using EQ-5D

Time Frame

at the begginning and up to 1 week after ulcer had healed

Title

Quality of life VLU-Qol

Description

Increasing in individual's quality of life using VLU-Qol

Time Frame

at the begginning and up to 1 week after ulcer had healed

Title

Quality of life CCVLUQ

Description

Increasing in individual's quality of life using VLU-Qol

Time Frame

at the begginning and up to 1 week after ulcer had healed

Title

Health Economic Assessment

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juliana Puggina, MD

Phone

+5511988604601

juliana.puggina@usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Igor R Sincos, PhD

Phone

+5511984477382

igorsincos@usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Igor R Sincos, PhD

Organizational Affiliation

University of São Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juliana Puggina, MD

Organizational Affiliation

University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

05403-010

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juliana Puggina, MD

Phone

+5511988604601

juliana.puggina@usp.br

First Name & Middle Initial & Last Name & Degree

Debora Nolli

Phone

+5511999707101

vuert.trial@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32928070

Citation

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.

Results Reference

derived

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Venous Ulcer: Endovenous Radiofrequency Treatment Trial

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