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NCT05092620 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

Official title:
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05092620
Other study ID # HUM00193015
Secondary ID 5U24DK122927-03
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 30, 2024

Study information
Verified date February 2024
Source University of Michigan
Contact Katy Clark, MA
Phone 7346156767
Email DFC-DCC-PM@umich.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 30, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Indiana University Indianapolis Indiana
United States University of Miami Miami Florida
United States Stanford University Palo Alto California
United States University of California, San Francisco San Francisco California

Sponsors (6)
Lead Sponsor Collaborator
University of Michigan Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of California, San Francisco, University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participants consenting Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall Up to 2 years
Primary Biospecimens collected Proportion of biospecimens collected, by type, from among those expected, by study and overall Up to 2 years
See also
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