Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients of both sexes aged over 18 years
- people with skin ulcers of the lower limbs for at least 3 months
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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