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Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
NCT06569238 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Conventional bacterial culture
- DEVICE Rapid diagnostic group using mNGS technology
Study Locations (2)
Michigan
- University of Michigan — Ann Arbor
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2024-09-05 |
| Est. Completion | 2026-02-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06569238
The ClinicalTrials.gov registry entry for NCT06569238 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which Conventional bacterial culture is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06569238 reports 2 study locations spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06569238 about?
NCT06569238 is a clinical study titled "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 feas...
What is the current status of trial NCT06569238?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2024-09-05. Estimated completion is 2026-02-18.
What conditions does trial NCT06569238 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Diabetic Foot Ulcer, Wound. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06569238?
The interventions under investigation include: Conventional bacterial culture (DIAGNOSTIC_TEST), Rapid diagnostic group using mNGS technology (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06569238?
This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06569238 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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