Wound Assessment Using Spectral Imaging US

Diabetes Clinical Trial

Official title:

Wound Assessment Using Spectral Imaging US

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415683
• Other study ID #: CT-2022-01-CIP
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: SpectralMD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SpectralMD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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