NCT00701974

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

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	collagenase (IRUXOL)	patients will be treated with collagenase one time per day.
BIOLOGICAL	collagenase (Kollagenase)	patients will be treated with collagenase one time per day.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-06-19
• Last updated: 2022-11-03

Locations

1 site across 1 country: Brazil