Diabetic Foot UlcerNCT05092620
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
An observational study of Diabetic Foot Ulcer, run by University of Michigan at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 142 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2021to 17 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult diabetic patients with diabetic foot ulcer
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Indiana University
Indianapolis, Indiana, 46202
University of Miami
Miami, Florida, 33126
Stanford University
Palo Alto, California, 94305
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, diabetic foot ulcer, DFU, wound, wound healing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants consenting
Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall
Measured: Up to 2 years
Biospecimens collected
Proportion of biospecimens collected, by type, from among those expected, by study and overall
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 May 2021
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Why it stopped: The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Miami, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Responsible party
- Principal investigator, Cathie Spino, ScD, University of Michigan
- Investigators
- Brian Schmidt, DPM, Principal investigator, University of MichiganCathie Spino, ScD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092620
- Sponsor's protocol ID
- HUM00193015
- Other IDs
- 5U24DK122927-03
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
- ClinicalTrials.gov ID
- NCT05092620
- Acronym / sponsor ID
- HUM00193015
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, diabetic foot ulcer, DFU, wound, wound healing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Indiana University, University of Miami, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult diabetic patients with diabetic foot ulcer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Schmidt, DPM principal investigator
University of Michigan
Cathie Spino, ScD study chair
University of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by University of Michigan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants consenting (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.