Diabetic Foot Ulcers Microbiome and Pathogen Identification

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Foot Ulcer; Wound
• Intervention / Treatment: Procedure: Wound debridement

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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,

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infected DFU cohort; 25 participants that have an infected DFU will be enrolled.	Procedure: Wound debridement; 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.
Non-infected DFU cohort; 75 non-infected participants with DFU will be enrolled.	Procedure: Wound debridement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Brian Schmidt, DPM, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Wound Infection; Wound assessments; Wound's microbiome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: HUM00214995; K23DK131261 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No