Chronic Wounds With Different EtiologiesNCT01750203
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
An observational study of Chronic Wounds With Different Etiologies, run by Systagenix Wound Management at 1 site in United States.
Trial summary
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Wounds With Different Etiologies
- What is being tested?
- Swabs
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects (greater than 18 years old), presenting at participating clinical sites with wounds of different etiologies, who are willing to provide informed consent and who meet the inclusion / exclusion criteria, will be prospectively enrolled
Who may be able to join
- Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
- Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
- Subject is 18 years of age or older.
- Subject agrees to complete all aspects of the study and provides Informed Consent
Who cannot join
- Subject is less than 18 years of age.
- Target wound contains a malignancy
- Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
- Subject is confirmed to be positive for HIV or hepatitis.
- Subject is unable or unwilling to provide informed consent.
- Subjects deemed inappropriate for the study by the site's Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.
- Conditions
- Chronic Wounds With Different Etiologies
- Being tested
- Swabs
- Keywords
- Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds
- Medical subject headings
- Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwabsOther
There is no intervention only swabs are being used to collect wound fluid samples
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No cohort as this study is not using a treatment or intervention only swabs are being collected. Receives: Other: Swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biochemical differences between clinically infected and non infected wounds.
Wound exudate (fluid) swab samples from different etiologies of wounds will be collected. Subjects who have wounds that do not show clinical signs of infection, as well as Subjects who have wounds that do show clinical signs of infection will be enrolled. a maximum of four (4) swab sample from Subjects from whom Informed Consent has been obtained. The swabs will be subjected to various tests methods that may include, but are not limited to, the following: 1) quantitative bacterial cultures (for aerobic and / or anaerobic bacteria), 2) "for research use only" testing on test formats currently in development by the sponsor (note: this data will not be used to support regulatory filings, such as CE marking or FDA submissions for U.S. market clearance), 3) molecular microbiology, and 4) protease analysis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Wounds With Different EtiologiesStudies 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
- Observational
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Systagenix Wound Management
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750203
- Sponsor's protocol ID
- SBIR-001-A
- Other IDs
- Systagenix
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
- ClinicalTrials.gov ID
- NCT01750203
- Acronym / sponsor ID
- SBIR-001-A
- Conditions
- Chronic Wounds With Different Etiologies
- Keywords
- Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Systagenix Wound ManagementIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Dec 2012 (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.
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: SwabsNo cohort as this study is not using a treatment or intervention only swabs are being collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (greater than 18 years old), presenting at participating clinical sites with wounds of different etiologies, who are willing to provide informed consent and who meet the inclusion / exclusion criteria, will be prospectively enrolled
Key inclusion criteria (4 listed)
- Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
- Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
- Subject is 18 years of age or older.
- Subject agrees to complete all aspects of the study and provides Informed Consent
Key exclusion criteria (6 listed)
- Subject is less than 18 years of age.
- Target wound contains a malignancy
- Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
- Subject is confirmed to be positive for HIV or hepatitis.
- Subject is unable or unwilling to provide informed consent.
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 |
|---|---|---|
| SwabsThere is no intervention only swabs are being used to collect wound fluid samples | Other | No treatment |
Primary outcome
The biochemical differences between clinically infected and non infected wounds.
Time frame: 1 day
Wound exudate (fluid) swab samples from different etiologies of wounds will be collected. Subjects who have wounds that do not show clinical signs of infection, as well as Subjects who have wounds that do show clinical signs of infection will be enrolled. a maximum of four (4) swab sample from Subjects from whom Informed Consent has been obtained. The swabs will be subjected to various tests methods that may include, but are not limited to, the following: 1) quantitative bacterial cultures (for aerobic and / or anaerobic bacteria), 2) "for research use only" testing on test formats currently in development by the sponsor (note: this data will not be used to support regulatory filings, such as CE marking or FDA submissions for U.S. market clearance), 3) molecular microbiology, and 4) protease analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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.
Tom Serena, MD principal investigator
SerenaGroup, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Wounds With Different Etiologies, run by Systagenix Wound Management at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Dec 2012. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The biochemical differences between clinically infected and non infected wounds. (time frame: 1 day). 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 20 Dec 2012.