MolecuLightDX Measurement Feature Clinical Validation

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

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.

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