DiabetesNCT04591691
C-myc Biomarker Study for Diabetic Foot Ulcers
An observational study of Diabetes and Diabetic Foot, run by University of Michigan at 6 sites in United States.
Trial summary
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- How many people
- 140 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Oct 2020to 20 Jul 2023
- 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 Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
- Foot ulcer of diabetic etiology, with all of the following characteristics:
Show all 14Show fewer
- Ulcer size > 0.5 cm2 and < 12 cm2 at least 2 cm from any other ulcer, and
- Ulcer with Wagner grade 1 or 2 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
- Patients with neuropathic or neuro-ischemic ulcers with adequate circulation to allow healing to the affected extremity as demonstrated by at least 2 of the following within 6 months of Visit 1:
- Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
- Absolute ankle pressure ≥ 70 mm Hg, or
- Toe pressure ≥ 40 mmHg, or
- TcPO2 ≥ 40 mmHg
- Willingness to comply with standard of care which includes an initial surgical debridement of the wound.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient participating in an interventional clinical trial within 1 month of Visit 1
- Currently receiving radiation to target area or chemotherapy
- Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
- Participant with active severe infection or osteomyelitis at the time of screening
- History of cancer within last 3 years, other than non-melanoma skin cancer
Show all 11Show fewer
- Known or suspected malignancy of current study ulcer
- Use of adjunctive therapy within previous 30 days
- Currently receiving medication considered to be systemic glucocorticoids
- Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral vascular intervention
- Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Indiana University Health
Indianapolis, Indiana, 46202
University of Miami
Miami, Florida, 33126
University of Pittsburgh
Pittsburgh, Pennsylvania, 25261
University of California - San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
Official title: Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers - C-myc and Phosphorylated Glucocorticoid Receptor
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound
- Keywords
- biomarker, C-myc, phosphorylated glucocorticoid receptor, DFC, Diabetic Foot Consortium
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with complete wound healing by week 12, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Oct 2020
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Stanford University, University of Miami, University of Pittsburgh, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Cathie Spino, ScD, University of Michigan
- Investigators
- Marjana Tomic-Canic, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591691
- Sponsor's protocol ID
- HUM00168547
- Other IDs
- 1U24DK122927-01
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2020
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers - C-myc and Phosphorylated Glucocorticoid Receptor
- ClinicalTrials.gov ID
- NCT04591691
- Acronym / sponsor ID
- HUM00168547
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound
- Keywords
- biomarker, C-myc, phosphorylated glucocorticoid receptor, DFC, Diabetic Foot Consortium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Indiana University, Stanford University, University of Miami, University of Pittsburgh, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 19 Oct 2020 (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.
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.
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 Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer
Key inclusion criteria (14 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
Key exclusion criteria (11 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient participating in an interventional clinical trial within 1 month of Visit 1
- Currently receiving radiation to target area or chemotherapy
- Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
- Participant with active severe infection or osteomyelitis at the time of screening
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
Proportion of participants with complete wound healing by week 12, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
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.
Marjana Tomic-Canic principal investigator
University of Miami
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Foot, run by University of Michigan at 6 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 12 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 6 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with complete wound healing by week 12, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements (time frame: Up to 12 weeks). 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 12 Jul 2024.