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

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ClinicalTrials.gov Identifier: NCT05092620
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : January 25, 2023
Sponsor:
Collaborators:
Indiana University
University of Miami
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Information provided by (Responsible Party):
Cathie Spino, ScD, University of Michigan

Tracking Information
First Submitted Date October 22, 2021
First Posted Date October 25, 2021
Last Update Posted Date January 25, 2023
Actual Study Start Date May 1, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2021)
  • 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
  • Biospecimens collected [ Time Frame: Up to 2 years ]
    Proportion of biospecimens collected, by type, from among those expected, by study and overall
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
Official Title Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma, serum, urine, wound tissue, wound dressing
Sampling Method Non-Probability Sample
Study Population Adult diabetic patients with diabetic foot ulcer
Condition Diabetic Foot Ulcer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2021)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Katy Clark, MA 7346156767 DFC-DCC-PM@umich.edu
Contact: Tina Lucas, BS DFC-DCC-PM@umich.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05092620
Other Study ID Numbers HUM00193015
5U24DK122927-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Cathie Spino, ScD, University of Michigan
Original Responsible Party Same as current
Current Study Sponsor University of Michigan
Original Study Sponsor Same as current
Collaborators
  • Indiana University
  • University of Miami
  • University of California, San Francisco
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University
Investigators
Principal Investigator: Brian Schmidt, DPM University of Michigan
Study Chair: Cathie Spino, ScD University of Michigan
PRS Account University of Michigan
Verification Date January 2023