Understanding the microbiome in diabetic foot ulcers
The Role of The Microbiome in Diabetic Foot Ulcers (DFU)
University of Michigan · NCT05556954
This study looks at how the germs in diabetic foot ulcers affect healing and infections to help identify people who might face complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05556954 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of the microbiome in diabetic foot ulcers and its impact on infection development and wound healing. By analyzing the bacterial presence in these wounds, researchers hope to identify individuals at risk for complications. The study will involve wound debridement as part of the assessment process. Participants will be monitored to gather data on their healing progress and microbiome characteristics.
Who should consider this trial
Good fit: Ideal candidates include patients with diabetes mellitus who have diabetic foot ulcers and a hemoglobin A1c of 12% or less.
Not a fit: Patients who are pregnant, have uncontrolled blood glucose, or are currently infected with COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for diabetic foot ulcers, potentially reducing the risk of infections and amputations.
How similar studies have performed: Other studies have shown promise in understanding the microbiome's role in wound healing, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Brian Schmidt, DPM — University of Michigan
- Study coordinator: Kourtney Noll
- Email: kneibaue@med.umich.edu
- Phone: 734-763-4156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Foot Ulcer, Diabetes Mellitus, Wound, Wound Infection, Wound assessments, Wound's microbiome