Wound InfectionNCT05196880
Biofilm Correlation and Validation
An observational study of Wound Infection, run by MolecuLight Inc. at 1 site in Canada.
Trial summary
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection
- What is being tested?
- MolecuLight DX Imaging Device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2022to 8 Nov 2023
- How long will I take part?
- 01 Days
- 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: Male and female subjects presenting with acute or chronic wounds
Who may be able to join
- Patients presenting with acute or chronic wounds
- 18 years or older
- Willing to consent
Who cannot join
- Treatment with an investigational drug within 1 month of enrolment
- Any contra-indication to regular wound care
- Inability or unwillingness to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.
- Conditions
- Wound Infection
- Being tested
- MolecuLight DX Imaging Device
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLight DX Imaging DeviceDevice
The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Patients with negative clinical suspicion of Biofilm containing wounds(CSB-). Receives: Device: MolecuLight DX Imaging Device | |
| ARM 2 | Patients with positive clinical suspicion of Biofilm containing wounds(CSB+) Receives: Device: MolecuLight DX Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Feb 2022
- Primary completion15 May 2022
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies 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
- 40 participants (actual)
- Target duration
- 01 Days
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196880
- Sponsor's protocol ID
- 21-002
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
- ClinicalTrials.gov ID
- NCT05196880
- Acronym / sponsor ID
- 21-002
- Conditions
- Wound Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 19 Jan 2022 (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 prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 01 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | Device: MolecuLight DX Imaging DevicePatients with negative clinical suspicion of Biofilm containing wounds(CSB-). |
| ARM 2 | – | Device: MolecuLight DX Imaging DevicePatients with positive clinical suspicion of Biofilm containing wounds(CSB+) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects presenting with acute or chronic wounds
Key inclusion criteria (3 listed)
- Patients presenting with acute or chronic wounds
- 18 years or older
- Willing to consent
Key exclusion criteria (3 listed)
- Treatment with an investigational drug within 1 month of enrolment
- Any contra-indication to regular wound care
- Inability or unwillingness to 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 |
|---|---|---|
| MolecuLight DX Imaging DeviceThe MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment. | Device | ARM 1, ARM 2 |
Primary outcome
Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load
Time frame: 3 months
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infection, 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 3 inclusion and 3 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 25 Jun 2026. 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?
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?
Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load (time frame: 3 months). 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 25 Jun 2026.