Wound Assessment Using Spectral Imaging US

Completed

Conditions studied: Diabetes, Diabetic Foot, Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT05415683

Run by

SpectralMD

People needed

400

Starts

2022-06-22

Expected to finish

2024-08-30

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Surgery of Foot and Ankle — Encino, California, United States
• New Hope Podiatry Group — Los Angeles, California, United States
• Northwell Hospital — Lake Success, New York, United States
• Cutting Edge Research LLC — Circleville, Ohio, United States
• Gentle Foot Care — Grove City, Ohio, United States
• Gentle Foot Care — Hilliard, Ohio, United States
• Foot and Ankle Specialist of Ohio — Mentor, Ohio, United States
• Worthington Foot and Ankle — Worthington, Ohio, United States
• Lower Extremity Institute of Research & Therapy (LEIRT) — Youngstown, Ohio, United States
• University of Tennessee Health Science Center, Wound Care Center @ Regional One — Memphis, Tennessee, United States
• West Houston Foot and Ankle — Missouri City, Texas, United States

Full record on ClinicalTrials.gov

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