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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 : October 28, 2021
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

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.

Condition or disease
Diabetic Foot Ulcer

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. Biospecimens collected [ Time Frame: Up to 2 years ]
    Proportion of biospecimens collected, by type, from among those expected, by study and overall


Biospecimen Retention:   Samples Without DNA
Plasma, serum, urine, wound tissue, wound dressing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult diabetic patients with diabetic foot ulcer
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092620


Contacts
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Contact: Katy Clark, MA 7346156767 katymc@med.umich.edu
Contact: Brandi Gizinski, MBA

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Shannon Meyer       smeyer72@stanford.edu   
Principal Investigator: Geoffrey Gurtner, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Onorio Antonucci    415-353-4379    onorio.antonucci@ucsf.edu   
Principal Investigator: Michael Conte, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33126
Contact: Aliette Espinosa    305-689-3376      
Principal Investigator: Robert S Kirsner, MD, PhD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Bryce Hockman    317-278-2715      
Principal Investigator: Chandan Chandan, PhD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Aaron Burant    734-615-0552    aburant@med.umich.edu   
Principal Investigator: Rodica Busui, MD, PhD         
Sponsors and Collaborators
University of Michigan
Indiana University
University of Miami
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Investigators
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Principal Investigator: Brian Schmidt, DPM University of Michigan
Study Chair: Cathie Spino, ScD University of Michigan
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Responsible Party: Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan
ClinicalTrials.gov Identifier: NCT05092620    
Other Study ID Numbers: HUM00193015
5U24DK122927-03 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cathie Spino, ScD, University of Michigan:
Diabetes, diabetic foot ulcer, DFU, wound, wound healing
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases