WoundNCT03290690
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa
An observational study of Wound and Chronic Leg Ulcer, run by MolecuLight Inc. at 1 site in Canada.
Trial summary
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Chronic Leg Ulcer, Wound Contamination
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2017to 30 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be treated at the Scarborough and Rouge Hospital as per the standard of care, which includes use of the MolecuLight i:X imaging device and targeted sampling of regions with bacterial fluorescence for microbiological analysis. Patients will be identified as candidates and consented by the study's principle investigator. The images which would be acquired for this study are currently part of the routine clinical wound care assessment process in the principle investigator's wound care clinic. However, during study enrollment subjects will be given as much time as required for their understanding of the basic study, to understand that their participation is optional, to understand that they will receive standard of care wound treatment whether or not they choose to participate, and to have any potential questions addressed.
Who may be able to join
- Male or female patients presenting with a chronic wound (wound duration > 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology
- 18 years or older
Who cannot join
- Treatment with an investigational drug within 1 month before study enrolment
- Inability to consent to medical photography (i.e. inability to understand consent process)
- Any contra-indication to routine wound care and/or monitoring
- Prior participation of the patient in this study (for the same wound or a different wound).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Scarborough and Rouge Hospital
Scarborough Village, Ontario, M1E 4B9
Rose Raizman, RN-EC, 416-886-2328, rraizman@rougevalley.ca
About this study
Official title: A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Pseudomonas Aeruginosa in Chronic Wounds
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.
- Conditions
- Wound, Chronic Leg Ulcer, Wound Contamination
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | All subjects in this study will have their wounds imaged and assessed in the following manner: Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds
Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start4 Aug 2017
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scarborough Rouge Hospital
- Responsible party
- Sponsor
- Investigators
- Rose Raizman, Principal investigator, Scarborough Rouge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290690
- Sponsor's protocol ID
- 16-102
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Pseudomonas Aeruginosa in Chronic Wounds
- ClinicalTrials.gov ID
- NCT03290690
- Acronym / sponsor ID
- 16-102
- Conditions
- Wound, Chronic Leg Ulcer, Wound Contamination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Collaborators
- Scarborough Rouge Hospital
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 25 Sep 2017 (actual)
- 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 non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | –All subjects in this study will have their wounds imaged and assessed in the following manner: Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be treated at the Scarborough and Rouge Hospital as per the standard of care, which includes use of the MolecuLight i:X imaging device and targeted sampling of regions with bacterial fluorescence for microbiological analysis. Patients will be identified as candidates and consented by the study's principle investigator. The images which would be acquired for this study are currently part of the routine clinical wound care assessment process in the principle investigator's wound care clinic. However, during study enrollment subjects will be given as much time as required for their understanding of the basic study, to understand that their participation is optional, to understand that they will receive standard of care wound treatment whether or not they choose to participate, and to have any potential questions addressed.
Key inclusion criteria (2 listed)
- Male or female patients presenting with a chronic wound (wound duration > 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology
- 18 years or older
Key exclusion criteria (4 listed)
- Treatment with an investigational drug within 1 month before study enrolment
- Inability to consent to medical photography (i.e. inability to understand consent process)
- Any contra-indication to routine wound care and/or monitoring
- Prior participation of the patient in this study (for the same wound or a different wound).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds
Time frame: 1 hour
Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Rose Raizman principal investigator
Scarborough Rouge Hospital
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 Wound and Chronic Leg Ulcer, run by MolecuLight Inc. at 1 site in Canada.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liis Teene (6472551519, lteene@moleculight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds (time frame: 1 hour). 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 6 Mar 2020.