Diabetic Foot Ulcers Microbiome and Pathogen Identification

NCT05556954 | Completed

• 2 other identifiers: HUM00214995K23DK131261
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer; Diabetes Mellitus; Wound

Keywords

Wound Infection; Wound assessments; Wound's microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants

  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

Study Arms (2)

Infected DFU cohort

25 participants that have an infected DFU will be enrolled.

Procedure: Wound debridement

Non-infected DFU cohort

75 non-infected participants with DFU will be enrolled.

Procedure: Wound debridement

Interventions

Wound debridement PROCEDURE

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.

Infected DFU cohort; Non-infected DFU cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Foot Ulcer; Diabetes Mellitus; Wounds and Injuries; Wound Infection

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Study Officials

• Brian Schmidt, DPM

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: October 13, 2022
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)