Status:
SUSPENDED
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
Lead Sponsor:
Azidus Brasil
Conditions:
Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- Patients of both sexes aged over 18 years
- people with skin ulcers of the lower limbs for at least 3 months
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00701974
Start Date
February 1 2008
End Date
February 1 2008
Last Update
November 3 2022
Active Locations (1)
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1
Lal Clinica
Valinhos, São Paulo, Brazil