Clinical trial NCT05415683: Wound Assessment Using Spectral Imaging US
Official title: Wound Assessment Using Spectral Imaging US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetic Foot
Diabetic Foot Ulcer
Lead sponsor: SpectralMD
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with DFUs undergoing SWC treatment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Data Collection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Surgery of Foot and Ankle
state: California
city: Los Angeles
country: United States
facility: New Hope Podiatry Group
state: California
city: Lake Success
country: United States
facility: Northwell Hospital
state: New York
city: Circleville
country: United States
facility: Cutting Edge Research LLC
state: Ohio
city: Grove City
country: United States
facility: Gentle Foot Care
state: Ohio
city: Hilliard
country: United States
facility: Gentle Foot Care
state: Ohio
city: Mentor
country: United States
facility: Foot and Ankle Specialist of Ohio
state: Ohio
city: Worthington
country: United States
facility: Worthington Foot and Ankle
state: Ohio
city: Youngstown
country: United States
facility: Lower Extremity Institute of Research & Therapy (LEIRT)
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center, Wound Care Center @ Regional One
state: Tennessee
city: Missouri City
country: United States
facility: West Houston Foot and Ankle
state: Texas
Study officials:
References: