Pressure UlcerPhase 3NCT02004626
Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.
A Phase 3 study testing Collagenase and Kollagenase in people with Pressure Ulcer, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Collagenase and Kollagenase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infected ulcers;
- Limited ulcers;
- Ulcers with indication for surgical debridement ;
- Periostitis ;
- Obesity II( BMI ≥ 35 ) ;
- Severe malnutrition ( BMI < 16 )
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Objectives:
The primary objective of efficacy is the reduction in the area of devitalized tissue based on the photographic record.
The secondary objective is to evaluate:
- formation of granulation tissue;
- the lesion reduction during treatment;
- the healing process of the Pressure Ulcer (PU) range of PUSH;
- the safety of the investigational product.
Study Plan:
- Estimated 92 research participants;
- Aged between ≥ 18 years and ≤ 80 years - both sexes;
- Visits from 1 to 10;
- The maximum lasting period in the study for each research participant will be approximately four weeks.
Evaluations During Study:
Evaluation of Digital Photography: The digital photographic record can provide the relative size of the wound, the tissue color and condition of the surrounding skin. The evaluation of digital photograph of each research participant will be performed by the classification assigned to the decrease of devitalized area and tissue e repair related to the time of healing and observed the formation of granulation tissue and epithelialization from standardized photographs.
Evaluation by PUSH Scales:
In order to provide an evaluation instrument of PUs in Brazil, so that satisfies the simplicity of the use in different clinical scenarios keeping its measurement properties, as previously attested from its original version, the PUSH scale was adapted into Portuguese.
The PUSH Scale considers three parameters or sub - scales of the wound healing process and treatment outcomes: wound area, amount of exudate present on the wound, appearance of the wound.
Retention of Records:
The investigator shall retain all documentation of the study over a period of at least five years from the end of the study. The Sponsor or its designee will provide a list of all documentation which should be kept by the Investigator.
Monitoring:
All aspects of the study will be carefully monitored by Cristália Pharmaceutical Chemicals Ltda. or designated representative of it (Clinical Research Organization - CRO) for evaluations related to good clinical practice and applicable local regulations.
Case Report Forms:
The Monitor will be available if the investigator, or other person of his team, needs information and guidance.
The Monitor of the study should have permanent access to all documentation and it is his obligation to ensure that the Case Report Forms are complete and completed correctly, as well as checking if the data are described according to the source documents, in order to eliminate interferences that may compromise the accuracy of the data generated in the clinical trial.
Audit and Inspections:
Authorized representatives of the Sponsor or designees, regulatory authority or the Ethics Committee of the institution may conduct audits or inspections during or after the study conclusion.
Collecting Data:
The information corresponding to the data of interest from the study will be collected and recorded in Case Report forms provided by Sponsor, and filled from the information contained in the source documents.
Documents are considered sources for study: medical records used by the professional at the time of the visits, diagnostic tests or image.
Informed Consent of Trial:
The Principal Investigator will ensure that the research participant receive verbally and in writing all relevant information about the nature, purpose, the test drug, the possible risks and benefits of the study.
Research participants will be notified that they are free to discontinue the study at any time. That they will have the opportunity to ask questions and to have sufficient time to consider the information received.
Formation of the database:
The database of the study will be assembled with the data from the Case Report Forms. Doubts and discrepancies will generate questions (queries) written to the Principal Investigator.
- Conditions
- Pressure Ulcer
- Being tested
- Collagenase, Kollagenase
- Keywords
- Collagenase, Phase III, National, Noninferiority, Double-blind, Multicenter, Prospective.
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenaseDrug
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.
KollagenaseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Kollagenase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A month.
Secondary outcomes (4)
Injury reduction.
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.
Measured: A month.
Granulation tissue formation.
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.
Measured: A month.
Healing process of PU.
Evolution of the healing process of PU by PUSH Scale.
Measured: A month.
Adverse events.
Frequency and percentage of adverse effects occurrence by the participants of the research.
Measured: A month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newco Trials Pesquisa Científica Ltda
- Responsible party
- Sponsor
- Investigators
- Norton Marcos S. Castro, Medic, Principal investigator, Clínica Dr. Norton Sayeg Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004626
- Sponsor's protocol ID
- CRT071
- Status last verified
- Jul 2015
- First submitted
- 28 Oct 2013
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02004626
- Acronym / sponsor ID
- CRT071
- Conditions
- Pressure Ulcer
- Keywords
- Collagenase, Phase III, National, Noninferiority, Double-blind, Multicenter, Prospective.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Newco Trials Pesquisa Científica Ltda
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
The primary objective of efficacy is the reduction in the area of devitalized tissue based on the photographic record.
The secondary objective is to evaluate:
- formation of granulation tissue;
- the lesion reduction during treatment;
- the healing process of the Pressure Ulcer (PU) range of PUSH;
- the safety of the investigational product.
Study Plan:
- Estimated 92 research participants;
- Aged between ≥ 18 years and ≤ 80 years - both sexes;
- Visits from 1 to 10;
- The maximum lasting period in the study for each research participant will be approximately four weeks.
Evaluations During Study:
Evaluation of Digital Photography: The digital photographic record can provide the relative size of the wound, the tissue color and condition of the surrounding skin. The evaluation of digital photograph of each research participant will be performed by the classification assigned to the decrease of devitalized area and tissue e repair related to the time of healing and observed the formation of granulation tissue and epithelialization from standardized photographs.
Evaluation by PUSH Scales:
In order to provide an evaluation instrument of PUs in Brazil, so that satisfies the simplicity of the use in different clinical scenarios keeping its measurement properties, as previously attested from its original version, the PUSH scale was adapted into Portuguese.
The PUSH Scale considers three parameters or sub - scales of the wound healing process and treatment outcomes: wound area, amount of exudate present on the wound, appearance of the wound.
Retention of Records:
The investigator shall retain all documentation of the study over a period of at least five years from the end of the study. The Sponsor or its designee will provide a list of all documentation which should be kept by the Investigator.
Monitoring:
All aspects of the study will be carefully monitored by Cristália Pharmaceutical Chemicals Ltda. or designated representative of it (Clinical Research Organization - CRO) for evaluations related to good clinical practice and applicable local regulations.
Case Report Forms:
The Monitor will be available if the investigator, or other person of his team, needs information and guidance.
The Monitor of the study should have permanent access to all documentation and it is his obligation to ensure that the Case Report Forms are complete and completed correctly, as well as checking if the data are described according to the source documents, in order to eliminate interferences that may compromise the accuracy of the data generated in the clinical trial.
Audit and Inspections:
Authorized representatives of the Sponsor or designees, regulatory authority or the Ethics Committee of the institution may conduct audits or inspections during or after the study conclusion.
Collecting Data:
The information corresponding to the data of interest from the study will be collected and recorded in Case Report forms provided by Sponsor, and filled from the information contained in the source documents.
Documents are considered sources for study: medical records used by the professional at the time of the visits, diagnostic tests or image.
Informed Consent of Trial:
The Principal Investigator will ensure that the research participant receive verbally and in writing all relevant information about the nature, purpose, the test drug, the possible risks and benefits of the study.
Research participants will be notified that they are free to discontinue the study at any time. That they will have the opportunity to ask questions and to have sufficient time to consider the information received.
Formation of the database:
The database of the study will be assembled with the data from the Case Report Forms. Doubts and discrepancies will generate questions (queries) written to the Principal Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase | Active comparator | Drug: CollagenaseEach 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. |
| Kollagenase | Active comparator | Drug: KollagenaseEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- Infected ulcers;
- Limited ulcers;
- Ulcers with indication for surgical debridement ;
- Periostitis ;
- Obesity II( BMI ≥ 35 ) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagenaseConduction 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. | Drug | Collagenase |
| KollagenaseConduction 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. | Drug | Kollagenase |
Primary outcome
Devitalized tissue reduction.
Time frame: A month.
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.
4 secondary outcomes
Injury reduction.
Time frame: A month.
Granulation tissue formation.
Time frame: A month.
Healing process of PU.
Time frame: A month.
Adverse events.
Time frame: A month.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norton Marcos S. Castro, Medic principal investigator
Clínica Dr. Norton Sayeg Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagenase and Kollagenase in people with Pressure Ulcer, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Devitalized tissue reduction. (time frame: A month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.