Safety assessment and dose of fibrin sealant derived from snake venom in the treatment of wounds.

Phase 1

• Conditions: Venous ulcer; C14.907.927.730

• Registration Number: RBR-9mbdj3
• Lead Sponsor: Faculdade de Medicina de Botucatu - Unesp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified