Ulcers
Conditions
Keywords
Non-inferiority based on efficiency
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.
Interventions
BIOLOGICALcollagenase (IRUXOL)
patients will be treated with collagenase one time per day.
BIOLOGICALcollagenase (Kollagenase)
patients will be treated with collagenase one time per day.
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed