Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

NCT ID: NCT06569238

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2026-03-31

Brief Summary

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers.

Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

Detailed Description

Participants will have tissue taken per standard of care at the baseline visit. In addition, participants will complete of a comprehensive medical history questionnaire, Michigan Neuropathy questionnaires, and have assessments of the foot ulcer or wound. The study team will follow participants for approximately 12 weeks.

Initial antibiotic therapy to treat diabetic foot ulcer infections are determined by participants treating provider and are based on clinical characteristics, drug allergies or sensitivities, and suspected causative pathogen (i.e., bacteria). In this study, the identification of pathogens using mNGS will be given to the treating physician and may result in additional or different antibiotics.

The decision for antibiotic prescription(s) to treat the diabetic foot ulcer infection will be made by treating providers. The antibiotic plan will be updated according to final culture results (usually 4-6 days following culture of tissue). For those participants randomized to the mNGS cohort, the results (usually 24-36 hours following culture of tissue) will be shared with the treating physician. The treating physician may provide additional or different treatment than initially prescribed.

Conditions

Diabetic Foot Ulcer; Diabetes Mellitus; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Conventional bacterial culture

Wound tissue removed will be sent for standard of care evaluation.

Group Type: ACTIVE_COMPARATOR

Conventional bacterial culture

Intervention Type: DIAGNOSTIC_TEST

Participants will have DFU ulcer tissue collected and sent to the laboratory (per usual care practices) that includes the use of conventional bacterial culture analysis (i.e., plates).

Conventional bacterial culture plus rapid diagnostic group

Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS).

Group Type: EXPERIMENTAL

Conventional bacterial culture

Intervention Type: DIAGNOSTIC_TEST

Participants will have DFU ulcer tissue collected and sent to the laboratory (per usual care practices) that includes the use of conventional bacterial culture analysis (i.e., plates).

Rapid diagnostic group using mNGS technology

Intervention Type: DEVICE

Participants will have DFU ulcer tissue collected and have metagenomics sequencing performed. The name of the devices listed for this study are the Illumina MiSeq System with MiSeq Reagent Kit V2 from Illumina and the MinION sequencer (Oxford Nanopore Technologies).

Interventions

Conventional bacterial culture

Participants will have DFU ulcer tissue collected and sent to the laboratory (per usual care practices) that includes the use of conventional bacterial culture analysis (i.e., plates).

Intervention Type: DIAGNOSTIC_TEST

Rapid diagnostic group using mNGS technology

Participants will have DFU ulcer tissue collected and have metagenomics sequencing performed. The name of the devices listed for this study are the Illumina MiSeq System with MiSeq Reagent Kit V2 from Illumina and the MinION sequencer (Oxford Nanopore Technologies).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with diabetes mellitus
• Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)

o DFU Infection status will be clinically recorded at time of enrollment according to Infectious Disease Society of America (IDSA): mild, moderate, or severe infection

• 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 a HbA1c of greater than 12%
• Bilateral wound or ulcer
• Current infection of Coronavirus disease 2019 (COVID19)
• Unable to provide informed consent or are unwilling to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Brian Schmidt

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Schmidt, DPM

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

K23DK131261

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00251960

Identifier Type: -

Identifier Source: org_study_id