NCT03293836|UnknownDMC
Venous Ulcer: Endovenous Radiofrequency Treatment Trial
VUERT
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VUERT
Sponsor study identifier
Secondary identifiers
OTHER · U1111-1194-4910
interventional
84
1 country
1
Study Start
January 1, 2015
Actual (reported)Primary Completion
October 31, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2015
Actual (reported)March 20, 2017
Actual (reported)September 26, 2017
Actual (reported)October 31, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Ulcer Recurrence
1 year
Quality of life SF-36
Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
Receive only compressive treatment
Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
Individual receive multilayer compressive bandage once a week
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
São Paulo, São Paulo, 05403-010, Brazil
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.
Igor R Sincos, PhD
University of Sao Paulo
Juliana Puggina, MD
University of Sao Paulo
First Submitted
March 20, 2017
First Posted
September 26, 2017
Study Start
January 1, 2015
Actual (reported)Primary Completion
October 31, 2017
Estimated (date passed)Negative Pressure Vs. Compression in Venous Ulcers
at the begginning and up to 1 week after ulcer had healed
Quality of life EQ- 5D
at the begginning and up to 1 week after ulcer had healed
Quality of life VLU-Qol
at the begginning and up to 1 week after ulcer had healed
Quality of life CCVLUQ
at the begginning and up to 1 week after ulcer had healed
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 26, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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