This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.
Study Type
OBSERVATIONAL
Enrollment
418
no intervention
University of California - San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
Time frame: 1 up to 16 weeks after wound closure
Time to DFU wound recurrence after complete wound healing
Time frame: Up to 16 weeks after wound closure
Participant self-report of DFU wound recurrence
Time frame: 16 weeks
Clinician assessment of DFU wound recurrence
Concordance between participant self-report and clinician assessment of DFU wound recurrence is important to provide confidence in the use of patient-reports for the primary endpoint.
Time frame: 16 weeks
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