MolecuLightDX Measurement Feature Clinical Validation

NCT06682923 | Recruiting

• 1 other identifier: 24-002
• Study Type: observational
• Target: 72
• 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

RECRUITING

SHN Research Institute

Scarborough Village, Ontario, M1E 4B9, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Laura Jones-Donaldson, PhD

CONTACT

416-542-5507; ljones@moleculight.com

Hanna Varonina, MSc, CCRP

CONTACT

416-542-5531; hvaronina@moleculight.com

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 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-09

Locations

CA (2)