BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Inclusion criteria

• Age ≥ 22 years
• Eligible wounds include all wound etiologies including but not limited to DFUs, VLUs, pressure injuries, and open postsurgical wounds.
• Presence of at least one target wound of sufficient size to allow:

Complete imaging using the investigational device, and collection of tissue biopsy samples, as required by the study protocol

• The target wound must be located in an anatomical region that permits: Full visualization, appropriate positioning for imaging, and safe and feasible biopsy sampling.

• Written informed consent possible
• Wound suitable for fluorescence imaging under IFU conditions with the study device and the comparator device (e.g., no excessive exudate obscuring visualization

Exclusion criteria

• The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are:

Too extensive to be captured within the device's field of view, positioned on curved, recessed, or otherwise inaccessible regions (e.g., deep sacral clefts, interdigital spaces).

• The target wound is too small to support the required biopsy procedures without compromising participant safety or data quality.
• Treatment with experimental medication within the last month
• Lack of ability to consent
• Contraindications for standard wound care or monitoring
• Strong therapeutic anticoagulation (e.g., direct oral anticoagulants and warfarin);
• Known bleeding diathesis or coagulation disorder that increases risk of biopsy-related complications
• Contraindications to local anesthesia or biopsy
• Patients with wounds that are not suitable for biopsy, including tunnelling wounds and wounds with fistula formation
• Wounds that cannot meet technical imaging requirements (e.g., excessive exudate, severe artifacts, calcification/crust preventing visualization).