Foot UlcerNCT05556954
Diabetic Foot Ulcers Microbiome and Pathogen Identification
An observational study of Foot Ulcer and Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Foot Ulcer, Diabetes Mellitus, Wound
- What is being tested?
- Wound debridement
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 4 Jun 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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,
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Foot Ulcer, Diabetes Mellitus, Wound
- Being tested
- Wound debridement
- Keywords
- Wound Infection, Wound assessments, Wound's microbiome
- Medical subject headings
- Foot Ulcer, 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.
Wound debridementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Infected DFU cohort | 25 participants that have an infected DFU will be enrolled. Receives: Procedure: Wound debridement | |
| Non-infected DFU cohort | 75 non-infected participants with DFU will be enrolled. Receives: Procedure: Wound debridement |
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 (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers
Measured: Baseline to 12 weeks
Secondary outcomes (6)
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).
Measured: Baseline to 12 weeks
Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants
Measured: Baseline to 12 weeks
Number of days to infection resolution for the DFU infected diabetic foot ulcer participants
Measured: Baseline 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
Post-study percentage change of wound surface area (cm2) for both cohorts
Measured: Baseline to 12 weeks
Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start13 Oct 2022
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 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
- NCT05556954
- Sponsor's protocol ID
- HUM00214995
- Other IDs
- K23DK131261
- Status last verified
- Aug 2025
- First submitted
- 22 Sep 2022
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of The Microbiome in Diabetic Foot Ulcers (DFU)
- ClinicalTrials.gov ID
- NCT05556954
- Acronym / sponsor ID
- HUM00214995
- Conditions
- Foot Ulcer, Diabetes Mellitus, Wound
- Keywords
- Wound Infection, Wound assessments, Wound's microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 27 Sep 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected DFU cohort | – | Procedure: Wound debridement25 participants that have an infected DFU will be enrolled. |
| Non-infected DFU cohort | – | Procedure: Wound debridement75 non-infected participants with DFU will be enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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,
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Wound debridementParticipant 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. | Procedure or surgery | Infected DFU cohort, Non-infected DFU cohort |
Primary outcome
The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers
Time frame: Baseline to 12 weeks
6 secondary outcomes
The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants
Time frame: Baseline to 12 weeks
Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants
Time frame: Baseline to 12 weeks
Number of days to infection resolution for the DFU infected diabetic foot ulcer participants
Time frame: Baseline 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
Post-study percentage change of wound surface area (cm2) for both cohorts
Time frame: Baseline to 12 weeks
Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts
Time frame: Baseline to 4 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 19 Aug 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Ulcer and Diabetes Mellitus, run by University of Michigan at 1 site 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 3 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 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers (time frame: Baseline to 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 19 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.