Diabetic Foot Ulcers Microbiome and Pathogen Identification

Study Overview
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Brief Summary
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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.

Official Title
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The Role of The Microbiome in Diabetic Foot Ulcers (DFU)

Conditions
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Foot Ulcer, Diabetes Mellitus, Wound

Intervention / Treatment
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* Procedure: Wound debridement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infected DFU cohort<br>25 participants that have an infected DFU will be enrolled. | Procedure: Wound debridement<br>* 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.<br>|
| Non-infected DFU cohort<br>75 non-infected participants with DFU will be enrolled. | Procedure: Wound debridement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers |  | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to 12 weeks | 
| Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants |  | Baseline to 12 weeks | 
| Number of days to infection resolution 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Infection, Wound assessments, Wound's microbiome