This research is being done because people with diabetes have reduced healing capacity and prone to develop infections of foot wounds. This can be problematic because wounds that become infected may result in amputation and more severe complications. New evidence suggests that a better understanding of the microbiome of wounds (e.g., bacterial presence) may provide information about wound healing and provide an earlier opportunity to identify an individual who may be prone to develop diabetic foot infection in their wound. Therefore, the purpose of this study is to evaluate the role of the microbiome of the diabetic foot ulcer in development of infection and wound healing. Once the role of the microbiome is confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible.
Study Type
OBSERVATIONAL
Enrollment
103
Participant that are having usual care visits for management of diabetic foot ulcers will be enrolled into this study. The procedure is done as part of standard of care. Tissue from the samples will be analyzed for this study. Aliquoting and Deoxyribonucleic acid (DNA) extraction will be done on the specimens. Bacterial DNA from biospecimens will be isolated, quantified, amplified, and sequenced.
University of Michigan
Ann Arbor, Michigan, United States
The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers
Time frame: Baseline to 12 weeks
The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants
Defined as improvement of greater or equal to 2 clinical signs (Local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge) with no requirement for additional antibiotic(s).
Time frame: Baseline to 12 weeks
Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants
Time frame: Baseline to 12 weeks
Number of days to infection resolution for the DFU infected diabetic foot ulcer participants
Time frame: Baseline to 12 weeks
The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4
Time frame: Baseline to 4 weeks
Post-study percentage change of wound surface area (cm2) for both cohorts
Time frame: Baseline to 12 weeks
Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts
Time frame: Baseline to 4 weeks
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