Clinical trial NCT05556954: Diabetic Foot Ulcers Microbiome and Pathogen Identification
Official title: The Role of The Microbiome in Diabetic Foot Ulcers (DFU)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Foot Ulcer
Diabetes Mellitus
Wound
Keywords: Wound Infection
Wound assessments
Wound's microbiome
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that are seen during usual care visits for management of diabetic foot ulcers in the University of Michigan (UM) Podiatry clinics within Metabolism, Endocrinology and Diabetes (MEND), the UM Comprehensive Wound Care Center, and from those consented participants in the Diabetic Foot Consortium (DFC) Biomarkers for Active Diabetic Foot Ulcers study,

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.


Eligibility 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.

Primary outcomes:
measure: The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants
timeFrame: Baseline to 12 weeks
measure: Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants
timeFrame: Baseline to 12 weeks
measure: Number of days to infection resolution for the DFU infected diabetic foot ulcer participants
timeFrame: Baseline to 12 weeks
measure: The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4
timeFrame: Baseline to 4 weeks
measure: Post-study percentage change of wound surface area (cm2) for both cohorts
timeFrame: Baseline to 12 weeks
measure: Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brian Schmidt, DPM
role: PRINCIPAL_INVESTIGATOR
References: