MolecuLightDX Measurement Feature Clinical Validation

This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wounds Wound of Skin Wounds and Injuries

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Mayer Institute, Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MolecuLight DX Imaging Device

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.

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

MolecuLight Inc.

Industry

Registry information

Official study title

Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 12, 2024
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting