The Role of The Microbiome in Diabetic Foot Ulcers (DFU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DFU patients with diabetes mellitus
- •Have a hemoglobin A1c[HbA1c] of 12% or less as measured within the last 6 months
- •Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria
- •Pregnant or lactating
- •Uncontrolled blood glucose as demonstrated by by a HbA1c of greater than 12%
- •Bilateral wound or ulcer
- •Current infection of Coronavirus (COVID-19)
- •Unable to provide informed consent or are unwilling to participate.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants(Baseline to 12 weeks)
- Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants(Baseline to 12 weeks)
- The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4(Baseline to 4 weeks)
- Post-study percentage change of wound surface area (cm2) for both cohorts(Baseline to 12 weeks)
- Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts(Baseline to 4 weeks)
- Number of days to infection resolution for the DFU infected diabetic foot ulcer participants(Baseline to 12 weeks)
Investigators
Brian Schmidt
Associate Professor of Internal Medicine
University of Michigan