Wound Assessment Using Spectral Imaging EU/UK

Study Overview
=================
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.

Official Title
-----------------
Wound Assessment Using Spectral Imaging

Conditions
-----------------
Diabetes, Diabetic Foot, Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Diagnostic Test: DV-SSP Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old. Subject has diabetes and an ulcer, at least four (4) weeks duration (as stated by patient) from the time of occurrence, located on the plantar surface of the foot or toes. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Foot Ulcer (DFU) Group<br>Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care | Diagnostic Test: DV-SSP Imaging<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |