Venous ulcer
Conditions
Interventions
Single group: 40 participants with chronic venous ulcers from Clinic of Chronic Ulcers - Department of Dermatology - Botucatu Medical School who will receive weekly dressings for 3 months with topica
Sponsors
Faculdade de Medicina de Botucatu - Unesp
Faculdade de Medicina de Botucatu - Unesp
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; to have at least one ulcer 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; to have a history of allergy to treatment with Unna boot; to have a history of allergy to treatment with essential fatty acid; known or suspected pregnancy; values coagulation outside the normal range ( Activated partial thromboplastin time more than 1.25 and time and prothrombin activity less than 70% or more than 100%); women of childbearing potential not using contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| 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.;Assessment the healing process by decreasing the areas of ulcers,characteristics of the ulcer bed, decreasing the amount of exudation, employing the technique of planimetry and softwear ImageJ.;Confirmation of dose: the proposal in the clinical protocol provides the minimum dose required to cover a maximum surface area of 60 square centimeters ulcer. | — |
Countries
Brazil
Contacts
Public ContactLuciana Abbade
Faculdade de Medicina de Botucatu - Unesp
Outcome results
None listed