Wound Assessment Using Spectral Imaging US
1 other identifier
observational
400
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedNovember 8, 2024
November 1, 2024
2 years
June 8, 2022
November 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Diabetic Foot Ulcer (DFU) Group
Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care
Interventions
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.
Eligibility Criteria
Adults with DFUs undergoing SWC treatment
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SpectralMDlead
Study Sites (11)
Surgery of Foot and Ankle
Encino, California, 91316, United States
New Hope Podiatry Group
Los Angeles, California, 90063, United States
Northwell Hospital
Lake Success, New York, 11042, United States
Cutting Edge Research LLC
Circleville, Ohio, 43920, United States
Gentle Foot Care
Grove City, Ohio, 43123, United States
Gentle Foot Care
Hilliard, Ohio, 43026, United States
Foot and Ankle Specialist of Ohio
Mentor, Ohio, 44060, United States
Worthington Foot and Ankle
Worthington, Ohio, 43085, United States
Lower Extremity Institute of Research & Therapy (LEIRT)
Youngstown, Ohio, 44512, United States
University of Tennessee Health Science Center, Wound Care Center @ Regional One
Memphis, Tennessee, 38103, United States
West Houston Foot and Ankle
Missouri City, Texas, 77459, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 13, 2022
Study Start
June 22, 2022
Primary Completion
June 28, 2024
Study Completion
August 30, 2024
Last Updated
November 8, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share