Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

Phase 2

Suspended

• Conditions: Ulcers
• Interventions: Biological: collagenase (IRUXOL); Biological: collagenase (Kollagenase)

• Registration Number: NCT00701974
• Lead Sponsor: Azidus Brasil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	collagenase (IRUXOL)	patients treated with collagenase (IRUXOL)
2	collagenase (Kollagenase)	patients treated with collagenase (Kollagenase)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lal Clinica; 🇧🇷 Valinhos, Sao Paulo, Brazil