Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Juliana Puggina84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Varicose Ulcer Varicose Veins of Lower Limb Saphenous Vein Injury

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ulcer Healing - 12 w

Ulcers was already healed after 12 weeks

Time frame: 12 weeks

Ulcer Healing - 24 w

Ulcers was already healed after 24 weeks

Time frame: 24 weeks

Secondary Outcomes

Ulcer Recurrence

Ulcer recurrence rate after 1 year of follow up

Time frame: 1 year

Quality of life SF-36

Increasing in individual's quality of life using SF 36

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

Quality of life EQ- 5D

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

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

Quality of life VLU-Qol

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

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

Quality of life CCVLUQ

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

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

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

Time frame: 1 year

Venous Ulcer: Endovenous Radiofrequency Treatment Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts