COMPLETED

Diabetic Foot Ulcers Microbiome and 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

This research is being done because people with diabetes have reduced healing capacity and prone to develop infections of foot wounds. This can be problematic because wounds that become infected may result in amputation and more severe complications. New evidence suggests that a better understanding of the microbiome of wounds (e.g., bacterial presence) may provide information about wound healing and provide an earlier opportunity to identify an individual who may be prone to develop diabetic foot infection in their wound. Therefore, the purpose of this study is to evaluate the role of the microbiome of the diabetic foot ulcer in development of infection and wound healing. Once the role of the microbiome is confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible.

Official Title

The Role of The Microbiome in Diabetic Foot Ulcers (DFU)

Quick Facts

Study Start:2022-10-13
Study Completion:2025-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05556954

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * DFU patients with diabetes mellitus
  2. * Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months
  3. * 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 by a HbA1c of greater than 12%
  3. * Bilateral wound or ulcer
  4. * Current infection of Coronavirus (COVID-19)
  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, 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 Date2022-10-13
Study Completion Date2025-06-04

Study Record Updates

Study Start Date2022-10-13
Study Completion Date2025-06-04

Terms related to this study

Keywords Provided by Researchers

  • Wound Infection
  • Wound assessments
  • Wound's microbiome

Additional Relevant MeSH Terms

  • Foot Ulcer
  • Diabetes Mellitus
  • Wound