Diabetes, Diabetic Foot, Diabetic Foot Ulcer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTDV-SSP Imaging
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.
Sponsors
SpectralMD
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old. * Subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes. * The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study. * The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy). * Subject understands and is willing to participate in the clinical study and can comply with required visits.
Exclusion criteria
* Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes. * Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. * Eligible DFU has associated untreated acute osteomyelitis or active infection * Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy. * Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection | 12 weeks | 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. |
Countries
United States
Outcome results
None listed