Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds

A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.

This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).

Inclusion Criteria:

• Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
• 18 years or older

Exclusion Criteria:

• Treatment with an investigational drug within 1 month before study enrolment
• Subjects with recent (<30 days) biopsy of target wound
• Subjects with wounds that cannot be completely imaged by study device due to anatomic location
• Inability to consent
• Any contra-indication to routine wound care and/or monitoring