MolecuLightDX Measurement Feature Clinical Validation

MolecuLight

Status: Enrolling

Conditions: Wound of Skin; Wounds

Treatments: Device: MolecuLight DX Imaging Device

Study type: Observational

Funder types: Industry

Identifiers

NCT06682923

24-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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