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

NCT00701974 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-11-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00701974 on ClinicalTrials.gov