- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092620
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
February 29, 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
Recruiting
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 (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katy Clark, MA
- Phone Number: 7346156767
- Email: DFC-DCC-PM@umich.edu
Study Contact Backup
- Name: Tina Lucas, BS
- Email: DFC-DCC-PM@umich.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Shannon Meyer
- Email: smeyer72@stanford.edu
-
Principal Investigator:
- Geoffrey Gurtner, MD
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Onorio Antonucci
- Phone Number: 415-353-4379
- Email: onorio.antonucci@ucsf.edu
-
Principal Investigator:
- Michael Conte, MD
-
-
Florida
-
Miami, Florida, United States, 33126
- Recruiting
- University of Miami
-
Contact:
- Aliette Espinosa
- Phone Number: 305-689-3376
-
Principal Investigator:
- Robert S Kirsner, MD, PhD
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University
-
Contact:
- Bryce Hockman
- Phone Number: 317-278-2715
-
Principal Investigator:
- Chandan Chandan, PhD
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Aaron Burant
- Phone Number: 734-615-0552
- Email: aburant@med.umich.edu
-
Principal Investigator:
- Rodica Busui, MD, PhD
-
-
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
Collaborators
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 (Estimated)
June 1, 2024
Study Completion (Estimated)
December 30, 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 (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
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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