Wound
Conditions
Brief summary
Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.
Detailed description
Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.
Interventions
DEVICEFluorescence Imaging Device
Hand-held, real-time fluorescence imaging device
Sponsors
MolecuLight Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects (inpatient/outpatient) presenting with a wound * Wound size less than 15 cm in length * 18 years or older
Exclusion criteria
* Treatment with an investigational drug within 1 month before study enrolment * Subjects with recent (\<30 days) biopsy or curettage of target wound * Subjects with wounds that cannot be completely imaged by study device due to anatomic location * Unable or unwilling to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance | 2 months | Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices |
Countries
Canada
Outcome results
None listed