Clinical trial phase I / II to evaluate the safety and best dose of the new fibrin sealant derived from snake venom in the treatment of venous ulcers - Study SELANTE I.

Faculdade de Medicina de Botucatu - Unesp0 个研究点开始时间: 2016年9月13日最近更新: 2023年5月29日

试验速览

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•Sign the term of free and informed consent; patients 18 years of age or older, of both sexes; chronic venous disease with chronic venous ulcers evidenced by one or more of the following signs: hyperpigmentation of the distal third of the lower limb, stasis eczema, lipodermatosclerosis, varicose veins; one or more ulcers whose time evolution is minimum of 6 weeks and a maximum of 5 years; display the sum of the areas of the ulcers of both members between 5 and 60 square centimeters, at least one ulcer whose major area is above 5 square centimeters; do not use the following drugs in the last two weeks prior to screening: venotonics, pentoxifylline, fibrinolytic drugs; Available to attend once a week for treatment.

•Leg ulcers of other etiologies ( causes hematological , neoplastic , infectious , among others) ; use of anticoagulants ; infected ulcers , or associated with erysipelas , cellulitis or lymphangitis; ulcer with critical colonization , ie ,large amount of exudate and / or foul and / or yellowish staining of the wound bed and / or green and / or red opaque odor and / or friable granulation tissue ; necrosis in the ulcer bed ; devitalized background with ulcer covering all your bed; venous ulcers associated with peripheral arterial disease that is characterized when the systolic ankle-brachial index is less than 0.9 and / or absence of distal pulses; being unable or does not wish to remain with compressive treatment of lower limb for seven days ; known or suspected pregnancy;
•values coagulation outside the normal range ( Activated partial thromboplastin time > 1.4 and international normalized ratio > 1.4 ); women of childbearing potential not using contraception.

发起方

Faculdade de Medicina de Botucatu - Unesp