Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
NCT ID: NCT00701974
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2/PHASE3
66 participants
INTERVENTIONAL
2008-02-29
2008-02-29
Brief Summary
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Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
patients treated with collagenase (IRUXOL)
collagenase (IRUXOL)
patients will be treated with collagenase one time per day.
2
patients treated with collagenase (Kollagenase)
collagenase (Kollagenase)
patients will be treated with collagenase one time per day.
Interventions
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collagenase (IRUXOL)
patients will be treated with collagenase one time per day.
collagenase (Kollagenase)
patients will be treated with collagenase one time per day.
Eligibility Criteria
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Inclusion Criteria
* people with skin ulcers of the lower limbs for at least 3 months
Exclusion Criteria
* injury over 2 years of evolution; injury infected
* neoplastic lesions in activity
* poorly controlled diabetes mellitus
* HAS poorly controlled
* signs of ischemia in the limb
* not offset any disease
* allergic to components of formula
* urticaria
* pregnancy
* breastfeeding
* emotional disturbance
18 Years
ALL
Yes
Sponsors
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Azidus Brasil
INDUSTRY
Responsible Party
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Locations
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Lal Clinica
Valinhos, São Paulo, Brazil
Countries
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Other Identifiers
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COLCRI0208
Identifier Type: OTHER
Identifier Source: secondary_id
COLCRI0208
Identifier Type: -
Identifier Source: org_study_id
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