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New DNA test could speed up infection treatment for diabetic foot ulcers

NCT ID NCT06569238

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a rapid DNA sequencing method (mNGS) could better identify bacteria in diabetic foot ulcers compared to standard lab cultures. 44 adults with diabetes and an infected foot ulcer had tissue samples analyzed using both methods. The goal was to see if this faster diagnosis could help doctors choose the right antibiotics more quickly and improve wound healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to faster, more targeted antibiotic treatment for diabetic foot ulcers, potentially improving healing.
What could go wrong
This was a small, completed study that only tested a diagnostic method, not a treatment. The results may not change patient outcomes or be widely applicable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

44 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot injury Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetic foot ulcer Wound

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48106, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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