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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05092620

Enrollment

142

Registered

2021-10-25

Start date

2021-05-01

Completion date

2024-04-17

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes, diabetic foot ulcer, DFU, wound, wound healing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results