ACTIVE_NOT_RECRUITING

Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

The Role of the Microbiome in Diabetic Foot Ulcers

Quick Facts

Study Start:2024-09-05
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06569238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with diabetes mellitus
  2. * Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)
  3. * Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months,
  4. * Stated willingness to comply with all study procedures and availability for the duration of the study
  1. * Pregnant or lactating
  2. * Uncontrolled blood glucose as demonstrated by a HbA1c of greater than 12%
  3. * Bilateral wound or ulcer
  4. * Current infection of Coronavirus disease 2019 (COVID19)
  5. * Unable to provide informed consent or are unwilling to participate

Contacts and Locations

Principal Investigator

Brian Schmidt, DPM
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48106
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Brian Schmidt, DPM, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2026-02

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Wound Infection
  • Wound assessments
  • Wound's microbiome
  • Next generation sequencing

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer
  • Diabetes Mellitus
  • Wound