Wound Assessment Using Spectral Imaging US

Completed

• Conditions: Diabetic Foot; Diabetes; Diabetic Foot Ulcer
• Interventions: Diagnostic Test: DV-SSP Imaging

• Registration Number: NCT05415683
• Lead Sponsor: SpectralMD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-06-22
• Primary Completion: 2024-06-28
• Study Completion: 2024-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic Foot Ulcer (DFU) Group	DV-SSP Imaging	Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

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; 🇺🇸 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