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

Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00701974
• Other study ID #: COLCRI0208
• Secondary ID: COLCRI0208
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: February 2008
• Est. completion date: February 2008

Study information

• Verified date: November 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 66
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Ulcer
• Ulcer
• Ulcers

Intervention

Biological:
• collagenase (IRUXOL)
patients will be treated with collagenase one time per day.
• collagenase (Kollagenase)
patients will be treated with collagenase one time per day.

Locations

Country	Name	City	State
Brazil	Lal Clinica	Valinhos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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