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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05415683
Other study ID # CT-2022-01-CIP
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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