MolecuLightDX Measurement Feature Clinical Validation

Last updated: November 8, 2024
Sponsor: MolecuLight Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Wounds

Treatment

MolecuLight DX Imaging Device

Clinical Study ID

NCT06682923
24-002
  • Ages > 22
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to consent

  • Willing to comply with all study procedures and availability for the duration of thestudy

  • 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

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 Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: MolecuLight DX Imaging Device
Phase:
Study Start date:
October 23, 2024
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • The Mayer Institute

    Hamilton, Ontario L8R 2R3
    Canada

    Active - Recruiting

  • SHN Research Institute

    Scarborough, Ontario M1E 4B9
    Canada

    Site Not Available

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