Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials

July 23, 2024 updated by: Cathie Spino, ScD, University of Michigan

Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials

The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.

Study Overview

Status

Terminated

Conditions

Detailed Description

Participants enrolling in a parent DFC research study will be concurrently approached about participating in the DFC Biorepository as well. If agreeable, participants will be asked to provide blood, urine, wound debridement tissue and wound dressing samples at the time of enrollment and once more if appropriate and as coincides with the primary study visit schedule. Participants will also be contacted via phone for every six months for two years thereafter to gather longitudinal data about their wound. Data and samples from the Biorepository, along with data collected during the primary study will be available to ancillary researchers.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Florida
      • Miami, Florida, United States, 33126
        • University of Miami
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult diabetic patients with diabetic foot ulcer

Description

Inclusion Criteria:

  • Provides written informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age > 18 years
  • Previous diagnosis of Type 1 or Type 2 diabetes or pre-diabetes per American Diabetes Association (ADA) guidelines
  • Inclusion in a part of any planned or approved DFC protocol

Exclusion Criteria:

  • An individual who meets exclusion criteria of the primary DFC protocol in which they are enrolled will also be excluded from participation in the biorepository program as well.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants consenting
Time Frame: Up to 2 years
Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall
Up to 2 years
Biospecimens collected
Time Frame: Up to 2 years
Proportion of biospecimens collected, by type, from among those expected, by study and overall
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Miami
University of California, San Francisco
Stanford University
Indiana University

Investigators

  • Principal Investigator: Brian Schmidt, DPM, University of Michigan
  • Study Chair: Cathie Spino, ScD, 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 Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

April 17, 2024

Study Completion (Actual)

April 17, 2024

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00193015
  • 5U24DK122927-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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