Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

University of Michigan

Status: Enrolling

Conditions: Wound; Diabetes Mellitus; Diabetic Foot Ulcer

Treatments: Diagnostic Test: Conventional bacterial culture; Device: Rapid diagnostic group using mNGS technology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06569238

K23DK131261 (U.S. NIH Grant/Contract)

HUM00251960

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

Conventional bacterial culture

Active Comparator group

Description:

Wound tissue removed will be sent for standard of care evaluation.

Treatment:

Diagnostic Test: Conventional bacterial culture

Conventional bacterial culture plus rapid diagnostic group

Experimental group

Description:

Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS).

Treatment:

Device: Rapid diagnostic group using mNGS technology

Diagnostic Test: Conventional bacterial culture