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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.
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, 2023
Estimated Study Completion Date :
December 30, 2024
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
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
Biospecimen Retention: Samples Without DNAPlasma, serum, urine, wound tissue, wound dressing
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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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
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:
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.
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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
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Stanford University
Palo Alto, California, United States, 94305
Contact: Shannon Meyer smeyer72@stanford.edu
Principal Investigator: Geoffrey Gurtner, MD
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Onorio Antonucci 415-353-4379 onorio.antonucci@ucsf.edu
Principal Investigator: Michael Conte, MD
University of Miami
Miami, Florida, United States, 33126
Contact: Aliette Espinosa 305-689-3376
Principal Investigator: Robert S Kirsner, MD, PhD
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Bryce Hockman 317-278-2715
Principal Investigator: Chandan Chandan, PhD
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Aaron Burant 734-615-0552 aburant@med.umich.edu
Principal Investigator: Rodica Busui, MD, PhD
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
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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:
HUM001930155U24DK122927-03 ( U.S. NIH Grant/Contract )
First Posted:
October 25, 2021 Key Record Dates
Last Update Posted:
January 24, 2023
Last Verified:
January 2023
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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 FootFoot UlcerDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin Ulcer
Skin DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesFoot Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
