Wound Assessment Using Spectral Imaging US

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot; Diabetic Foot Ulcer
• Intervention / Treatment: Diagnostic test: DV-SSP Imaging

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • Surgery of Foot and Ankle
    • Los Angeles, California, United States, 90063
      • New Hope Podiatry Group
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Hospital
  • Ohio
    • Circleville, Ohio, United States, 43920
      • Cutting Edge Research LLC
    • Grove City, Ohio, United States, 43123
      • Gentle Foot Care
    • Hilliard, Ohio, United States, 43026
      • Gentle Foot Care
    • Mentor, Ohio, United States, 44060
      • Foot and Ankle Specialist of Ohio
    • Worthington, Ohio, United States, 43085
      • Worthington Foot and Ankle
    • Youngstown, Ohio, United States, 44512
      • Lower Extremity Institute of Research & Therapy (LEIRT)
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Science Center, Wound Care Center @ Regional One
  • Texas
    • Missouri City, Texas, United States, 77459
      • West Houston Foot and Ankle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with DFUs undergoing SWC treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic Foot Ulcer (DFU) Group; Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care	Diagnostic test: DV-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.

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

Collaborators and Investigators

• Sponsor: SpectralMD

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: CT-2022-01-CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No