Effectiveness and safety evaluation of biomembrane hemicellulose versus curative collagenase in the treatment of chronic venous ulcers

Not Applicable

• Conditions: Varicose ulcers; C14.907.927.730

• Registration Number: RBR-2q5yjx
• 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: 2016-09-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Sign the consent form; ge above 18 years; of both sexes; Venous chronic disease with venous chronic ulcer 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 minimum evolution time is 6 weeks; present ulcer whose largest size is linear up to 20cm; Ulcers do not occur throughout the circumference of the member
Do not use venotonics drugs; pentoxifylline and fibrinolytic drugs in the last two weeks before the study

Exclusion Criteria

Having other etiologies ulcers (peripheral arterial disease, causes hematologic, neoplastic, infectious, etc.); Ulcer whose largest linear size is more than 20cm; Ulcers occurring throughout the limb circumference;
Infected ulcer, or when combined with erysipelas, cellulitis or lymphangitis;
Ulcers with critical colonization, or large amounts of exudate and/or foul odor and/or color of the green bed; Necrosis presence in ulcer bed; Venous ulcers associated with peripheral arterial disease that is characterized when the ankle-brachial systolic index (ABI) is less than 0.9 and / or absence of distal pulses, mainly tibioso; History of hypersensitivity to the proposed treatments

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent reduction in ulcer area during the 90 day treatment period: it will be calculated by the average ulcerated area before the initiation of treatment (T0), the 30th day after start of treatment (T30), day 60 (T60 ) and day 90 (T90). For the measurement of the area, each ulcer will be analyzed using the planimetric method using drawing the outlines in clear plastic film. Later it will be captured digital photos directly from these images. To create a frame of photographic measurements, the drawings will be photographed and placed a known size adhesive adjacent the edge of the design. From known external reference, establish the length of the relationship (pixels/mm) individualized for each picture and the computer to perform the manual tracing the perimeter of ulcers and will be calculated in your area pixel, and then transformed into cm2. Captured images will be analyzed using the ImageJ 1.37v software; There was a reduction of the area as a function of time, with no difference between groups