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NCT Number: NCT06569238

Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

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).

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Infections Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wound Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional bacterial culture

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

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).

Primary outcomes

  1. The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Percent of clinical resolved infected DFU for infected DFU participants with clinically resolved infection defined as improvement of greater or equal to two clinical signs of infection

    Time frame: Baseline up to 12 weeks

    Clinical signs of infection includes: local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge) with no requirement for additional antibiotics upon follow-up appointments.

  2. Total days of antibiotic therapy for the infected DFU participants

    Time frame: Baseline up to 12 weeks

  3. Number of days to infection resolution for the infected DFU participants

    Time frame: Baseline up to 12 weeks

  4. The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4

    Time frame: Baseline to 4 weeks

  5. The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study.

    Time frame: Baseline up to 12 weeks

  6. The percentage of participants with an infected DFU at baseline that are hospitalized for infection during the study.

    Time frame: Baseline up to 12 weeks

  7. Post study percentage change of wound surface area (cm2).

    Time frame: Baseline up to 12 weeks

  8. Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU

    Time frame: Baseline up to 12 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

The Role of the Microbiome in Diabetic Foot Ulcers

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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