Study Stopped
Sponsor's strategy
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers
1 other identifier
interventional
66
1 country
1
Brief Summary
Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedNovember 3, 2022
November 1, 2022
Same day
June 17, 2008
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events.
healing
Study Arms (2)
1
EXPERIMENTALpatients treated with collagenase (IRUXOL)
2
EXPERIMENTALpatients treated with collagenase (Kollagenase)
Interventions
Eligibility Criteria
You may qualify if:
- Patients of both sexes aged over 18 years
- people with skin ulcers of the lower limbs for at least 3 months
You may not qualify if:
- Lesion with a diameter larger than 12 cm ²
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
Lal Clinica
Valinhos, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
November 3, 2022
Record last verified: 2022-11