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Trial record 1 of 1 for:    VUERT
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Venous Ulcer: Endovenous Radiofrequency Treatment Trial (VUERT)

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ClinicalTrials.gov Identifier: NCT03293836
Recruitment Status : Unknown
Verified September 2017 by Juliana Puggina, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Juliana Puggina, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Varicose Ulcer Varicose Veins of Lower Limb Saphenous Vein Injury Procedure: Radiofrequency ablation Procedure: Multilayer Compressive Bandage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : August 31, 2018

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




Primary Outcome Measures :
  1. Ulcer Healing - 12 w [ Time Frame: 12 weeks ]
    Ulcers was already healed after 12 weeks

  2. Ulcer Healing - 24 w [ Time Frame: 24 weeks ]
    Ulcers was already healed after 24 weeks


Secondary Outcome Measures :
  1. Ulcer Recurrence [ Time Frame: 1 year ]
    Ulcer recurrence rate after 1 year of follow up

  2. Quality of life SF-36 [ Time Frame: at the begginning and up to 1 week after ulcer had healed ]
    Increasing in individual's quality of life using SF 36

  3. Quality of life EQ- 5D [ Time Frame: at the begginning and up to 1 week after ulcer had healed ]
    Increasing in individual's quality of life using EQ-5D

  4. Quality of life VLU-Qol [ Time Frame: at the begginning and up to 1 week after ulcer had healed ]
    Increasing in individual's quality of life using VLU-Qol

  5. Quality of life CCVLUQ [ Time Frame: at the begginning and up to 1 week after ulcer had healed ]
    Increasing in individual's quality of life using VLU-Qol

  6. Health Economic Assessment [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293836


Contacts
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Contact: Juliana Puggina, MD +5511988604601 juliana.puggina@usp.br
Contact: Igor R Sincos, PhD +5511984477382 igorsincos@usp.br

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo) Recruiting
Sao Paulo, São Paulo, Brazil, 05403-010
Contact: Juliana Puggina, MD    +5511988604601    juliana.puggina@usp.br   
Contact: Debora Nolli    +5511999707101    vuert.trial@gmail.com   
Sponsors and Collaborators
Juliana Puggina
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Igor R Sincos, PhD University of São Paulo
Principal Investigator: Juliana Puggina, MD University of São Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juliana Puggina, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03293836    
Other Study ID Numbers: Vuert trial
UTN ( Other Identifier: U1111-1194-4910 )
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juliana Puggina, University of Sao Paulo:
Varicose ulcer
Venous ulcer
Radiofrequency ablation
Perforating veins insufficiency
Varicose veins treatment
Additional relevant MeSH terms:
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Varicose Veins
Varicose Ulcer
Ulcer
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases