Phase
Condition
Varicose Veins
Vascular Diseases
Claudication
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who agree to the terms described in IC;
Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lowerlimbs;
Subjects with CVI ranked 3 to 5, according to CEAP scale;
Patients complaining of pain and swelling in the lower limbs secondary to IVC;
Subjects with good mental health that can respond adequately to the studyquestionnaires;
Subjects who agree to make any return visits for evaluation;
Exclusion
Exclusion Criteria:
Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
Subjects who have received treatment for varicose veins as laser, medication usetopical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 monthspreceding the study;
Patients with other diseases that may interfere with the study results: thrombosis,coagulation disorders and other diseases that the medical criteria, are important tobe excluded;
Pregnant or nursing women;
Presence of any medical condition that, according to the investigator, should preventthe patient from the study;
Participation in clinical trials in the twelve months preceding the study;
Patients with serious illnesses and uncontrolled that need multidrug treatment;
Patients on diuretics of any kind, regardless of pathology (hypertension, renal orliver disease);
Values of laboratory tests appropriate security; the Hemoglobin <10 mg / mL thecreatinine> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet countbelow 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
past medical history of hypersensitivity to drugs of the same pharmacological classesof substances under investigation;
Study Design
Connect with a study center
Lal Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, SP 13270000
BrazilSite Not Available
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