Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Capsicure, LLC
With
BioLab Holdings
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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).
Clareo Health | BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
