Diabetic Foot UlcerNCT06569238
Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
A study testing Conventional bacterial culture and Rapid diagnostic group using mNGS technology in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by University of Michigan at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound
- What is being tested?
- Conventional bacterial culture and Rapid diagnostic group using mNGS technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2024to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48106
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: The Role of the Microbiome in Diabetic Foot Ulcers
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).
Read the 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
- Being tested
- Conventional bacterial culture, Rapid diagnostic group using mNGS technology
- Keywords
- Wound Infection, Wound assessments, Wound's microbiome, Next generation sequencing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional bacterial cultureDiagnostic 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 technologyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional bacterial culture | Active comparator | Wound tissue removed will be sent for standard of care evaluation. Receives: Diagnostic Test: Conventional bacterial culture |
| Conventional bacterial culture plus rapid diagnostic group | Experimental | Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS). Receives: Diagnostic Test: Conventional bacterial culture; Device: Rapid diagnostic group using mNGS technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers
Measured: Baseline, 12 weeks
Secondary outcomes (8)
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
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.
Measured: Baseline up to 12 weeks
Total days of antibiotic therapy for the infected DFU participants
Measured: Baseline up to 12 weeks
Number of days to infection resolution for the infected DFU participants
Measured: Baseline up to 12 weeks
The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4
Measured: Baseline to 4 weeks
The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study.
Measured: Baseline up to 12 weeks
The percentage of participants with an infected DFU at baseline that are hospitalized for infection during the study.
Measured: Baseline up to 12 weeks
Post study percentage change of wound surface area (cm2).
Measured: Baseline up to 12 weeks
Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start5 Sep 2024
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to the control and intervention arms using block randomization. Only tissue review will be randomized.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Schmidt, University of Michigan
- Investigators
- Brian Schmidt, DPM, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569238
- Sponsor's protocol ID
- HUM00251960
- Other IDs
- K23DK131261
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiome in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06569238
- Acronym / sponsor ID
- HUM00251960
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound
- Keywords
- Wound Infection, Wound assessments, Wound's microbiome, Next generation sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to the control and intervention arms using block randomization. Only tissue review will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Conventional bacterial culture | Active comparator | Diagnostic Test: Conventional bacterial cultureWound tissue removed will be sent for standard of care evaluation. |
| Conventional bacterial culture plus rapid diagnostic group | Experimental | Diagnostic Test: Conventional bacterial culture, Device: Rapid diagnostic group using mNGS technologyWound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional bacterial cultureParticipants 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). | Diagnostic test | Conventional bacterial culture, Conventional bacterial culture plus rapid diagnostic group |
| Rapid diagnostic group using mNGS technologyParticipants 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). | Device | Conventional bacterial culture plus rapid diagnostic group |
Primary outcome
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
8 secondary outcomes
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
Total days of antibiotic therapy for the infected DFU participants
Time frame: Baseline up to 12 weeks
Number of days to infection resolution for the infected DFU participants
Time frame: Baseline up to 12 weeks
The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4
Time frame: Baseline to 4 weeks
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
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
Post study percentage change of wound surface area (cm2).
Time frame: Baseline up to 12 weeks
Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU
Time frame: Baseline up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Schmidt, DPM principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional bacterial culture and Rapid diagnostic group using mNGS technology in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.