Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

NCT02004626 | Withdrawn Phase 3

• 1 other identifier: CRT071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer

Keywords

Collagenase; Phase III; National; Noninferiority; Double-blind; Multicenter; Prospective.

Outcome Measures

Primary Outcomes (1)

• Devitalized tissue reduction.

  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.

  A month.

Secondary Outcomes (4)

• Injury reduction.

  A month.

• Granulation tissue formation.

  A month.

• Healing process of PU.

  A month.

• Adverse events.

  A month.

Study Arms (2)

Collagenase

ACTIVE COMPARATOR

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

Kollagenase

ACTIVE COMPARATOR

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

Interventions

Collagenase DRUG

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.

Collagenase

Kollagenase DRUG

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.

Kollagenase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead
• Newco Trials Pesquisa Científica Ltda: collaborator

Study Sites (1)

Clínica Dr. Norton Sayeg Ltda

São Paulo, São Paulo, 04063-001, Brazil

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Norton Marcos S. Castro, Medic

  Clínica Dr. Norton Sayeg Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

BR (1)