Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
| Registry | NCT03293836, acronym VUERT |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 84 (Estimated) |
| Sponsor | Juliana Puggina (Other); collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo |
| Conditions | Varicose Ulcer, Varicose Veins of Lower Limb, Saphenous Vein Injury |
| Interventions | Radiofrequency ablation, Multilayer Compressive Bandage (Procedure) |
| Dates | start 2015-01-01, primary completion 2017-10-31 (estimated), completion 2018-08-31 (estimated), first posted 2017-09-26, last updated 2017-09-26 |
| Locations | 1 site in Brazil |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Radiofrequency treatment | Experimental | Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage | Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment |
| Multilayer Compressive Bandage only | Active comparator | Procedure: Multilayer Compressive Bandage | Receive only compressive treatment |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo) | São Paulo, São Paulo | Brazil | Recruiting |