MolecuLightDX Measurement Feature Clinical Validation

MolecuLight Inc.34 enrolled

Overview

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

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

Conditions

Wounds Wound of Skin

Interventions

MolecuLight DX Imaging DeviceDEVICE

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

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

The Mayer Institute

Hamilton, Ontario, Canada

Judy Dan Centre for Hyperbaric Medicine & Advance Wound Care

North York, Ontario, Canada

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.