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| ID | Type | Description | Link |
|---|---|---|---|
| UTN | Other Identifier | U1111-1194-4910 |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency treatment | Experimental | Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment |
|
| Multilayer Compressive Bandage only | Active Comparator | Receive only compressive treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure | Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Healing - 12 w | Ulcers was already healed after 12 weeks | 12 weeks |
| Ulcer Healing - 24 w | Ulcers was already healed after 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Recurrence | Ulcer recurrence rate after 1 year of follow up | 1 year |
| Quality of life SF-36 | Increasing in individual's quality of life using SF 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana Puggina, MD | Contact | +5511988604601 | juliana.puggina@usp.br | |
| Igor R Sincos, PhD | Contact | +5511984477382 | igorsincos@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Igor R Sincos, PhD | University of Sao Paulo | Principal Investigator |
| Juliana Puggina, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo) | Recruiting | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32928070 | Derived | Puggina J, Sincos IR, Campos W Jr, Porta RMP, Dos Santos JB, De Luccia N, Puech-Leao P, Collares FB, da Silva ES. A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial). Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Multilayer Compressive Bandage | Procedure | Individual receive multilayer compressive bandage once a week |
|
| 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 | 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 | 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 | 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 | 1 year |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |