Status:
COMPLETED
Wound Assessment Using Spectral Imaging US
Lead Sponsor:
SpectralMD
Conditions:
Diabetes
Diabetic Foot
Eligibility:
All Genders
18+ years
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 pos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05415683
Start Date
June 22 2022
End Date
August 30 2024
Last Update
November 8 2024
Active Locations (11)
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1
Surgery of Foot and Ankle
Encino, California, United States, 91316
2
New Hope Podiatry Group
Los Angeles, California, United States, 90063
3
Northwell Hospital
Lake Success, New York, United States, 11042
4
Cutting Edge Research LLC
Circleville, Ohio, United States, 43920