Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569238
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Diabetic Foot Ulcer DFU Rapid Pathogen Identification
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of the Microbiome in Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Participants 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 participants will not be randomized to any treatment ie antibiotic therapy
Participants 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 participants will not be randomized to any treatment ie 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 ie 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 prescriptions 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
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 ie 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 prescriptions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None