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Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.
Patients (n = 50) with chronic wounds will be imaged using 2 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 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MolecuLight PID | Device | Hand-held, real-time fluorescence imaging device |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance | The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Sensitivity and specificity for detection of moderate/heavy bacterial load of PID FL-images to be equal to or greater than that of i:X FL-images when validated by microbiology gold truth | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Load quantification by sampling | Quantify difference in bacterial load reported by sampling using standard Levine technique (swabbing) compared to FL image-guided curettage scraping. | 2 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic wounds
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Linden | Judy Dan Research and Treatment Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Judy Dan Research and Treatment Center | North York | Ontario | M2R 1N5 | Canada |
There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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