Venous Ulcer: Endovenous Radiofrequency Treatment Trial (VUERT)

Juliana Puggina

Status: Unknown

Conditions: Saphenous Vein Injury; Varicose Veins of Lower Limb; Varicose Ulcer

Treatments: Procedure: Multilayer Compressive Bandage; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03293836

UTN (Other Identifier)

Vuert trial

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Radiofrequency treatment

Experimental group

Description:

Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment

Treatment:

Procedure: Multilayer Compressive Bandage

Procedure: Radiofrequency ablation

Multilayer Compressive Bandage only

Active Comparator group

Description:

Receive only compressive treatment

Treatment:

Procedure: Multilayer Compressive Bandage