Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Not Applicable

• Conditions: Saphenous Vein Injury; Varicose Ulcer; Varicose Veins of Lower Limb
• Interventions: Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage

• Registration Number: NCT03293836
• Lead Sponsor: Juliana Puggina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-03-20
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-25
• Last Update Submitted: 2017-09-25
• Study First Posted: 2017-09-26
• Last Update Posted: 2017-09-26
• Primary Completion: 2017-10-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency treatment	Multilayer Compressive Bandage	Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
Multilayer Compressive Bandage only	Multilayer Compressive Bandage	Receive only compressive treatment
Radiofrequency treatment	Radiofrequency ablation	Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment

Primary Outcome Measures

Name	Time	Method
Ulcer Healing - 12 w	12 weeks	Ulcers was already healed after 12 weeks
Ulcer Healing - 24 w	24 weeks	Ulcers was already healed after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Ulcer Recurrence	1 year	Ulcer recurrence rate after 1 year of follow up
Quality of life SF-36	at the begginning and up to 1 week after ulcer had healed	Increasing in individual's quality of life using SF 36
Quality of life EQ- 5D	at the begginning and up to 1 week after ulcer had healed	Increasing in individual's quality of life using EQ-5D
Quality of life VLU-Qol	at the begginning and up to 1 week after ulcer had healed	Increasing in individual's quality of life using VLU-Qol
Quality of life CCVLUQ	at the begginning and up to 1 week after ulcer had healed	Increasing in individual's quality of life using VLU-Qol
Health Economic Assessment	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

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo); 🇧🇷 Sao Paulo, São Paulo, Brazil