Clinical trial NCT06569238: Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
Official title: The Role of the Microbiome in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetes Mellitus
Wound
Keywords: Wound Infection
Wound assessments
Wound's microbiome
Next generation sequencing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to the control and intervention arms using block randomization. Only tissue review will be randomized.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline up to 12 weeks
measure: Total days of antibiotic therapy for the infected DFU participants
timeFrame: Baseline up to 12 weeks
measure: Number of days to infection resolution for the infected DFU participants
timeFrame: Baseline up to 12 weeks
measure: The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4
timeFrame: Baseline to 4 weeks
measure: The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study.
timeFrame: Baseline up to 12 weeks
measure: The percentage of participants with an infected DFU at baseline that are hospitalized for infection during the study.
timeFrame: Baseline up to 12 weeks
measure: Post study percentage change of wound surface area (cm2).
timeFrame: Baseline up to 12 weeks
measure: Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU
timeFrame: Baseline up to 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brian Schmidt, DPM
role: PRINCIPAL_INVESTIGATOR
References: