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TerminatedNCT05092620Updated Jul 24, 2024

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

An observational study in Diabetic Foot Ulcer, sponsored by University of Michigan. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by University of Michigan · Observational

Why this study was terminated
The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
142
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcer

Keywords

  • Diabetes, diabetic foot ulcer, DFU, wound, wound healing
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 142 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult diabetic patients with diabetic foot ulcer

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
142 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Participants consenting

    Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall

    Time frame: Up to 2 years

  2. Biospecimens collected

    Proportion of biospecimens collected, by type, from among those expected, by study and overall

    Time frame: Up to 2 years

07

Study locations

5 sites
  • Stanford University
    Palo Alto, California 94305, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • University of Miami
    Miami, Florida 33126, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05092620
Lead sponsor
University of Michigan
Collaborators
Indiana University, University of Miami, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
Responsible party
Cathie Spino, ScD (Research Professor of Biostatistics, SABER Director, University of Michigan) — Principal investigator
First posted
Oct 25, 2021
Start date
May 1, 2021
Primary completion
Apr 17, 2024
Completion
Apr 17, 2024
Last update
Jul 24, 2024

Study contacts

Brian Schmidt, DPM
principal investigator · University of Michigan
Cathie Spino, ScD
study chair · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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