MolecuLightDX Measurement Feature Clinical Validation

June 23, 2026 updated by: MolecuLight Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults 22 years and older with surface wounds

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MolecuLight Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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