Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor:
Collaborator:
Newco Trials Pesquisa Científica Ltda
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT02004626
First received: October 28, 2013
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority.

Its purpose is to determine the noninferiority in efficacy of an investigational product in relation to the product available in the market intended of treating pressure ulcers.


Condition Intervention Phase
Pressure Ulcer
Drug: Collagenase
Drug: Kollagenase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study Phase III, Randomized, Double-blind, Multicenter, National, to Evaluate the Non-inferiority in Efficacy of Investigational Product Regarding the Comparator Product, in Debridement of Devitalized Tissue in Uninfected Pressure Ulcers.

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • Devitalized tissue reduction. [ Time Frame: A month. ] [ Designated as safety issue: No ]
    Percentage of the area reduction of devitalized tissue, surrounding the injury total area and devitalized tissue for each 2D photographic record, with the use of standard metric, using the software IMAGE® J.


Secondary Outcome Measures:
  • Injury reduction. [ Time Frame: A month. ] [ Designated as safety issue: Yes ]
    Evaluation of the wound area, related to the greatest length (in cephalo-caudal direction) versus the greatest width (horizontal line from right to left) in square centimeters, using the software IMAGE® J.

  • Granulation tissue formation. [ Time Frame: A month. ] [ Designated as safety issue: Yes ]
    Classification assigned to the reduction of devitalized area and from tissue repair related to the time for healing and verified by formation of granulation and epithelialization tissue from standardized photographs using the software IMAGE® J.

  • Healing process of PU. [ Time Frame: A month. ] [ Designated as safety issue: Yes ]
    Evolution of the healing process of PU by PUSH Scale.

  • Adverse events. [ Time Frame: A month. ] [ Designated as safety issue: Yes ]
    Frequency and percentage of adverse effects occurrence by the participants of the research.


Estimated Enrollment: 92
Study Start Date: January 2015
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collagenase

Each gram of ointment contains :

Collagenase ...0.6 U

Vehicle qs ... 1 g

Presentation:

Topic use. 5 g tube of ointment containing smooth, lump-free , pale white to slightly brown with faint characteristic odor .

Dosage The ointment should have full contact with the entire injured area, and uniformly applied twice a day.

Drug: Collagenase

Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test.

Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start.

Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough).

Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue.

Photographic records.

Other Name: Collagenase
Active Comparator: Kollagenase

Each gram of ointment contains :

Collagenase ... 0.6 U

Vehicle qs ... 1 g

Presentation

Topic use. 5 g tube of ointment containing brownish clear, fat and weak characteristic odor.

Dosage The ointment should have full contact with all the injured area, being uniformly applied twice a day.

Drug: Kollagenase

Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test.

Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start.

Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough).

Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue.

Photographic records.

Other Name: Kollagenase

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both sexes;
  • Aged ≥ 18 years and ≤ 80 years;
  • Patients hospitalized;
  • Patients with leg ulcers in the sacral region with presence of devitalized/ necrotic tissue indicating conservative debridement;
  • Understanding, agreement and signing the Informed Consent Form (IFC), and the Authorization Term for the Image Use for publication of results

Exclusion Criteria:

  • Infected ulcers;
  • Limited ulcers;
  • Ulcers with indication for surgical debridement ;
  • Periostitis ;
  • Obesity II( BMI ≥ 35 ) ;
  • Severe malnutrition ( BMI < 16 )
  • Hemoglobin (HbA1c ) above the upper limit of normal (ULN ) ;
  • Coagulation Factor twice the ULN ;
  • Patients with pulmonary emphysema and / or Chronic Obstructive Pulmonary Disease (COPD) ;
  • Collagen diseases;
  • Psychiatric illnesses;
  • Patients using cytotoxic agents ;
  • Oncology patients under palliative care ;
  • Outpatients ;
  • Signs of limb ischemia ;
  • Urinary incontinence uncontrolled;
  • Fecal incontinence;
  • Diarrhea that in the opinion of the investigator , compromise the process of debridement;
  • Known allergy from the components of the formulas;
  • Pregnancy ;
  • Breastfeeding ;
  • Local and concomitant use of medications and / or products in the lesion: tyrothricin , gramicidin , tetracycline , hexachlorophene , heavy metals ( mercury, silver) , iodine , potassium permanganate , hydrogen peroxide , soap, detergent.
  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: NCT02004626

Contacts
Contact: Norton Marcos S. Castro, Medic 55-11-4306-4691

Locations
Brazil
Clínica Dr. Norton Sayeg Ltda
São Paulo, Brazil, 04063-001
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Newco Trials Pesquisa Científica Ltda
Investigators
Principal Investigator: Norton Marcos S. Castro, Medic Clínica Dr. Norton Sayeg Ltda
  More Information

No publications provided

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT02004626     History of Changes
Other Study ID Numbers: CRT071
Study First Received: October 28, 2013
Last Updated: August 7, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Collagenase
Phase III
National
Noninferiority
Double-blind
Multicenter
Prospective.

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

ClinicalTrials.gov processed this record on November 24, 2014