Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
Primary Purpose
Ulcers
Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
collagenase (IRUXOL)
collagenase (Kollagenase)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcers focused on measuring Non-inferiority based on efficiency
Eligibility Criteria
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
Sites / Locations
- Lal Clinica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
patients treated with collagenase (IRUXOL)
patients treated with collagenase (Kollagenase)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00701974
Brief Title
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Sponsor's strategy
Study Start Date
February 2008 (Actual)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers
Keywords
Non-inferiority based on efficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
patients treated with collagenase (IRUXOL)
Arm Title
2
Arm Type
Experimental
Arm Description
patients treated with collagenase (Kollagenase)
Intervention Type
Biological
Intervention Name(s)
collagenase (IRUXOL)
Intervention Description
patients will be treated with collagenase one time per day.
Intervention Type
Biological
Intervention Name(s)
collagenase (Kollagenase)
Intervention Description
patients will be treated with collagenase one time per day.
Primary Outcome Measure Information:
Title
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.
Time Frame
healing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lal Clinica
City
Valinhos
State/Province
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
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