ClinicalTrials.gg
CompletedNCT06682923Updated Jun 25, 2026

MolecuLightDX Measurement Feature Clinical Validation

An observational study in Wounds and Wound of Skin, sponsored by MolecuLight Inc.. Completed at 2 sites in Canada. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by MolecuLight Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
22 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Wounds
  • Wound of Skin

Browse trials for

03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 34 is below the median of 169 across 690 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

MolecuLight Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults 22 years and older with surface wounds

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Circumferential wound
  • Wound without clearly defined wound borders
  • Wound located in a difficult to reach/measure location
  • Any 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Interventions

  • DeviceMolecuLight DX Imaging Device

    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.

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: up to 6 months

07

Study locations

2 sites
  • The Mayer Institute
    Hamilton, Ontario L8R 2R3, Canada
  • Judy Dan Centre for Hyperbaric Medicine & Advance Wound Care
    North York, Ontario M2R 1N5, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Feb 2025, 3 months.

Of 47 industry-sponsored observational studies under Wounds and Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 63. This study's 3 months is below that.

Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.

Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2024
First posted
Nov 12, 2024
StartActual
Oct 23, 2024
Primary completionActual
Feb 20, 2025
CompletionActual
Feb 20, 2025
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682923
Lead sponsor
MolecuLight Inc.
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Oct 23, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
Jun 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion