Status:
ACTIVE_NOT_RECRUITING
Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot Ulcer
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 questionna...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06569238
Start Date
September 5 2024
End Date
March 1 2026
Last Update
January 7 2026
Active Locations (2)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48106
2
University of Michigan
Ann Arbor, Michigan, United States, 48109