Clinical trial NCT05092620: Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
Official title: Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes, diabetic foot ulcer, DFU, wound, wound healing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Indiana University
name: University of Miami
name: University of California, San Francisco
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Stanford University
First posted: 2021-10-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult diabetic patients with diabetic foot ulcer

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.

Eligibility 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.

Primary outcomes:
measure: Participants consenting
timeFrame: Up to 2 years
measure: Biospecimens collected
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brian Schmidt, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Cathie Spino, ScD
role: STUDY_CHAIR
References: