An observational study in Diabetes, Diabetic Foot and Diabetic Foot Ulcer, sponsored by University of Michigan. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by University of Michigan · Observational
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 418 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult diabetic patients with diabetic foot ulcer
In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:
Provides written informed consent.
At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Other: Observational
no intervention
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Michigan