MolecuLightDX Measurement Feature Clinical Validation

NCT06682923 | Completed

• 1 other identifier: 24-002
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Wounds; Wound of Skin

Outcome Measures

Primary Outcomes (1)

• Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler

  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

  up to 6 months

Interventions

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 22 years and older with surface wounds

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MolecuLight Inc.: lead

Study Sites (2)

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Location

Judy Dan Centre for Hyperbaric Medicine & Advance Wound Care

North York, Ontario, M2R 1N5, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: October 23, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CA (2)