Venous ulcer
Conditions
Interventions
Single group: 10 subjects with chronic venous ulcers from the Clinic of Chronic Ulcers Department of Dermatology, Botucatu Medical School who receive weekly dressings for 3 months with topical fibrin
Biological/vaccine
Sponsors
Faculdade de Medicina de Botucatu - Unesp
Centro de Estudos de Venenos e Animais Peçonhentos da Unesp (CEVAP)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of systemic adverse events through complete blood count, erythrocyte sedimentation rate (ESR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen and C-reactive protein (CRP) and medical appointment compared among the initial visit (pretreatment) and subsequent visits.;The results of laboratory tests did not change with statistical or clinical significance, that is, there were no systemic adverse events detected by these tests. Two participants had flu during the study follow-up, but not related to the investigational product. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determining safe dose to cover a maximum surface area of 60 square centimeters ulcer by counting the number of doses used per participant, considering that each dose is 2 ml of the product formed;Assessment the healing process by decreasing the areas of ulcers employing the technique of planimetry and softwear ImageJ compared among the initial visit (pretreatment) and subsequent visits..;Healing (complete epithelialization) ulcer by clinical evaluation.;Assessment of local adverse events: pain through application of Visual Analog Scale -VAS; itching, maceration of the edge of the ulcer, eczema, local infection, critical colonization, opening of a new ulcer by medical history and physical examination; increasing the ulcer area by employing the technique of planimetry and softwear ImageJ compared among the initial visit (pretreatment) and subsequent visits.;Result in relation to the total amount of sealant used per patient: the dose ranged from 6 to 22.8, with an average of 12.8 doses per patient;Result in relation to area reduction: 6 ulcers (33.3%) decreased their area compared to the initial areas.;Result in relation healing: 7 ulcers (38.8%) heal;Results in relation of Local adverse events: appearance of a new ulcer occurred in 5 participant (50%), 4 ulcers of 3 cases with myiasis (22,2%),3 ulcers of 2 cases with critical colonization (16,6%), , 1 participant showed an increase in your ulcer area (10%), local infection in one participant (10%). This events were not related to the product. Pain was reported by 2 participants in 5 ulcers with probable relationship to the sealant. | — |
Countries
Brazil
Contacts
Public ContactLuciana Abbade
Faculdade de Medicina de Botucatu - Unesp
Outcome results
None listed