Diabetic Foot Ulcers Microbiome and Pathogen Identification
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Details and patient eligibility
About
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.
Enrollment
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Volunteers
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.
Trial design
103 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Kourtney Noll
Data sourced from clinicaltrials.gov
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