No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for people with diabetic foot ulcers to help identify which ones have a better chance of healing. Participants will need to provide consent and attend regular visits while giving samples for study analysis.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with diabetes.
I have an open foot ulcer.
I agree to attend all visits and provide samples.
You may not be able to join if
I took part in another trial for diabetic foot ulcer in the last month.
I am currently receiving radiation therapy to my foot.
I have gangrene in any part of my foot.
I am scheduled for a procedure to improve blood flow in my leg in the next 4 weeks.
I have severe limb ischemia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Age 18 years or older.
3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\]
4. Open foot ulcer, defined as an o…
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Age 18 years or older.
3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\]
4. Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.
5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.
Exclusion Criteria:
1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
2. Currently receiving radiation to target area or chemotherapy.
3. Gangrene in any portion of the foot with the index ulcer.
4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
5. Severe limb ischemia (SVS WIfl Ischemia grade 3).
6. Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.
Contacts
No contact information available.
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