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

Terminated

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT05092620
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-25
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants consenting	Up to 2 years	Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall
Biospecimens collected	Up to 2 years	Proportion of biospecimens collected, by type, from among those expected, by study and overall

Trial Locations

Locations (5)

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States