WoundsNCT06682923
MolecuLightDX Measurement Feature Clinical Validation
An observational study of Wounds and Wound of Skin, run by MolecuLight Inc. at 2 sites in Canada.
Trial summary
This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Wounds, Wound of Skin
- What is being tested?
- MolecuLight DX Imaging Device
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Oct 2024to 20 Feb 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 22 years and older with surface wounds
Who may be able to join
- Willing to consent
- Willing to comply with all study procedures and availability for the duration of the study
- Male or female, aged over 22 years old
- Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
- Wound size is greater than 0.5 cm2
- The wound has well-defined wound borders
Who cannot join
- Circumferential wound
- Wound without clearly defined wound borders
- Wound located in a difficult to reach/measure location
- Any contra-indication to routine wound care and/or monitoring
- Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
- Tunneled or undermined wounds
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Mayer Institute
Hamilton, Ontario, L8R 2R3
Judy Dan Centre for Hyperbaric Medicine & Advance Wound Care
North York, Ontario, M2R 1N5
About this study
Official title: Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.
Read the detailed description
The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.
- Conditions
- Wounds, Wound of Skin
- Being tested
- MolecuLight DX Imaging Device
- 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.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler
Measured: up to 6 months
Secondary outcomes (1)
Mean and standard deviation of inter- and intra-user coefficient of variation (CV) for wound area measured by the MolecuLight device in manual and automaitc modes
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start23 Oct 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682923
- Sponsor's protocol ID
- 24-002
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2024
- 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
- Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
- ClinicalTrials.gov ID
- NCT06682923
- Acronym / sponsor ID
- 24-002
- Conditions
- Wounds, Wound of Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 12 Nov 2024 (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-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.
Detailed description
The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 22 years and older with surface wounds
Key inclusion criteria (6 listed)
- Willing to consent
- Willing to comply with all study procedures and availability for the duration of the study
- Male or female, aged over 22 years old
- Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
- Wound size is greater than 0.5 cm2
Key exclusion criteria (6 listed)
- Circumferential wound
- Wound without clearly defined wound borders
- Wound located in a difficult to reach/measure location
- Any contra-indication to routine wound care and/or monitoring
- Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
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 | – |
Primary outcome
Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler
Time frame: up to 6 months
1 secondary outcome
Mean and standard deviation of inter- and intra-user coefficient of variation (CV) for wound area measured by the MolecuLight device in manual and automaitc modes
Time frame: up to 6 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Wound of Skin, run by MolecuLight Inc. at 2 sites 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 6 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 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 2 sites 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?
Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler (time frame: up to 6 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.