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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
Health authority
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

Study Design


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
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