Rapid Pathogen Identification for Diabetic Foot Ulcers

N/A

Recruiting

Led By Brian Schmidt, DPM

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with an infected DFU with a surface area ≥0.5 square centimeter

Patients with diabetes mellitus

Must not have

Bilateral wound or ulcer

Unable to provide informed consent or are unwilling to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a new device for rapid pathogen diagnosis, called metagenomic next generation sequencing (mNGS), can help in treating infections and promoting wound healing in diabetic foot

Who is the study for?

This trial is for individuals with diabetic foot ulcers. Participants should have an infection in their ulcer and be willing to undergo tissue collection. The study excludes those who cannot give informed consent, are pregnant or breastfeeding, or have conditions that may interfere with the study.

What is being tested?

The trial is testing if rapid pathogen identification using metagenomic next generation sequencing (mNGS) can help in treating infections and healing wounds in diabetic foot ulcers compared to conventional bacterial culture methods.

What are the potential side effects?

Since participants will not be randomized to any treatment like antibiotic therapy, side effects are primarily related to tissue collection procedures which may include pain, bleeding, or infection at the site of sample collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My foot ulcer is infected and larger than 0.5 square cm.

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I have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have wounds or ulcers on both sides of my body.

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I am unable or unwilling to agree to participate in this study.

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I currently have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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