Varicose veins, venous insufficiency,varicose ulcer
Conditions
Interventions
E02.594
Intervention Groups: 03 groups
Control group: 01 group
1) Sclerotherapy by foam (polidocanol 3% + air - Tessari method) + dressing with elastic compression.
2) Endovenous Laser Ablation (EVLA) + dress
Procedure/surgery
Sponsors
Unidade de Pesquisa Clínica-Faculdade de Medicina de Botucatu - Unesp
Unidade de Pesquisa Clínica-Faculdade de Medicina de Botucatu - Unesp
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study will include male and female patients 18 years old or older, with no limits on the maximum age,with active venous ulcers (CEAP 6),primary varicose veins documented by ultrasound,and who agreed to the terms of the studyand signed the free, prior, and informed consent (FPIC).
Exclusion criteria
Exclusion criteria: Patients under 18 years of age; with venous anomalies (e.g. angiodysplasia); with history of deep venous thrombosis and post-thrombotic syndrome; in use of anticoagulants; varicose veins classified as CEAP 5 or less; who had previous saphenectomy in the affected limb; without surgical or anesthetic conditions; with ulcers with signs of active infection; pregnant, postpartum or breastfeeding women; patients with history of migraine; history of interatrial or arteriovenous communication; with active cellulitis or erysipelas; abnormal laboratory liver or kidney function (creatinine clearance below 30ml/m); with signs of active skin mycosis; with previously known retinal changes; history of alcohol or drug abuse; signs of arterial insufficiencyclinically present; signs of clinically decompensated comorbidities; who do not agree with the terms of the study or refuse to sign the free and informed consent (FPIC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints The efficacy endpoints to be considered will be wound healing, monthly healing rate - assessed by the proportion of healing speed as evaluated by the analyzes of area reduction - edema progression, non recanalization of the saphenous vein, evaluation of the impact on quality of life, and subjective evaluation by the analysis of the photo examiners. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints The safety endpoints that will be studied are: complications as pigmented stains over the venous segment treated, hematomas, paresthesia, thrombophlebitis ,heat-induced endovenous thrombosis, patient-reported pain,as well as major events such as burns, areas of skin necrosis, DVT and pulmonary embolism, syncope, amaurosis fugax, cardiac events. | — |
Countries
Brazil
Contacts
Public ContactRafael Elias Pimenta
Universidade Estadual Paulista - Julio de Mesquita Filho
Outcome results
None listed