Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

NARecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 5, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

February 28, 2026

Conditions
Diabetic Foot UlcerDiabetes MellitusWound
Interventions
DIAGNOSTIC_TEST

Conventional bacterial culture

Participants will have DFU ulcer tissue collected and sent to the laboratory (per usual care practices) that includes the use of conventional bacterial culture analysis (i.e., plates).

DEVICE

Rapid diagnostic group using mNGS technology

Participants will have DFU ulcer tissue collected and have metagenomics sequencing performed. The name of the devices listed for this study are the Illumina MiSeq System with MiSeq Reagent Kit V2 from Illumina and the MinION sequencer (Oxford Nanopore Technologies).

Trial Locations (2)

48106

RECRUITING

University of Michigan, Ann Arbor

48109

NOT_YET_RECRUITING

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Michigan

OTHER