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During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.
Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Foot Ulcer (DFU) Group | Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DV-SSP Imaging | Diagnostic Test | DeepView utilizes imaging data from DFUs to aid in health care providers' assessment of wound healing potential. It is intended to be used as an aid to health care providers in the management of DFU wounds and not as a standalone prediction device. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | The purpose of this study is to build a database for development and validation of a machine learning (ML) algorithm for diabetic foot ulcer (DFU) healing assessment using images obtained with the Spectral MD DeepView device. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with DFUs undergoing SWC treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery of Foot and Ankle | Encino | California | 91316 | United States | ||
| New Hope Podiatry Group |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Los Angeles |
| California |
| 90063 |
| United States |
| Northwell Hospital | Lake Success | New York | 11042 | United States |
| Cutting Edge Research LLC | Circleville | Ohio | 43920 | United States |
| Gentle Foot Care | Grove City | Ohio | 43123 | United States |
| Gentle Foot Care | Hilliard | Ohio | 43026 | United States |
| Foot and Ankle Specialist of Ohio | Mentor | Ohio | 44060 | United States |
| Worthington Foot and Ankle | Worthington | Ohio | 43085 | United States |
| Lower Extremity Institute of Research & Therapy (LEIRT) | Youngstown | Ohio | 44512 | United States |
| University of Tennessee Health Science Center, Wound Care Center @ Regional One | Memphis | Tennessee | 38103 | United States |
| West Houston Foot and Ankle | Missouri City | Texas | 77459 | United States |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |