Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SpectralMD
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Wound Assessment Using Spectral Imaging US
