Saphenous Vein Injury, Varicose Ulcer, Varicose Veins of Lower Limb
Conditions
Keywords
Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment
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.
Interventions
PROCEDURERadiofrequency ablation
Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
PROCEDUREMultilayer Compressive Bandage
Individual receive multilayer compressive bandage once a week
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Juliana Puggina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Ulcer Recurrence | 1 year | Ulcer recurrence rate after 1 year of follow up |
| 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 |
| 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 |
| 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 |
Countries
Brazil
Contacts
Primary ContactJuliana Puggina, MD
Backup ContactIgor R Sincos, PhD
Outcome results
None listed