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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00701974
First received: June 17, 2008
Last updated: October 22, 2010
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Ulcers
Biological: collagenase (IRUXOL)
Biological: collagenase (Kollagenase)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

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. [ Time Frame: healing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients treated with collagenase (IRUXOL)
Biological: collagenase (IRUXOL)
patients will be treated with collagenase one time per day.
Experimental: 2
patients treated with collagenase (Kollagenase)
Biological: collagenase (Kollagenase)
patients will be treated with collagenase one time per day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701974

Locations
Brazil
Lal Clinica
Valinhos, Sao Paulo, Brazil
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00701974     History of Changes
Other Study ID Numbers: COLCRI0208, colcri0208
Study First Received: June 17, 2008
Last Updated: October 22, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Non-inferiority based on efficiency

Additional relevant MeSH terms:
Skin Ulcer
Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014