Observational Study for Diabetic Foot Ulcer Biomarkers
This study is looking for better ways to understand and predict how diabetic foot ulcers (DFUs) heal. Researchers want to find "biomarkers" (signs in your body) that can tell if an ulcer is likely to heal well or not. This information could help doctors make more personalized treatment plans for you and improve future studies on wound healing. You can join if you are 18 or older, have been diagnosed with diabetes, and have an open foot ulcer. The study will follow how your wound heals, if you get infections, and if any amputations are needed over 52 weeks.
- Study design
- This is an observational study planning to enroll 5000 participants. It is designed to efficiently test multiple biomarkers.
- What's involved
- You would provide blood, wound fluid, wound dressings, and debridement tissue (if debridement is performed). Urine samples will also be collected if you agree.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your wound healing, DFU infections, and amputations will be measured for 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
DFC 004 Biomarkers for Active Diabetic Foot Ulcers
At a glance
Conditions
Where it's being run
8 sites across 7 statesWho to contact
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What this trial measures
- Wound Healing52 Weeks
Proportion of participants with complete wound healing by week 52, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements at two consecutive study visits 2 weeks apart.
- DFU Infections52 Weeks
Proportion of participants who develop infections of the index DFU among those with no infections at baseline.
- Amputations52 Weeks
Proportion of participants who have an amputation of the limb associated with the index DFU.
- Prediction Performance52 Weeks
Measures of prediction performance (e.g., predictive power, AUC, ROC, Akaike information criterion) of biomarker(s) for each of the clinical outcomes: Wound Healing, DFU Infections, and Amputations described above. Prediction performance is measured by multiple statistical measures to assess ability of the biomarker to predict event risk for each of the three clinical outcomes.
- Biospecimens Count52 Weeks
Proportion of eligible participants providing biospecimens by site, and by type (serum, plasma, wound fluid, wound dressings, wound debridement tissue, urine).
- Biospecimen Quality52 Weeks
Proportion of biospecimens of adequate quality by type.
- Standard of Care Prescription by Site52 Weeks
Proportion of sites that prescribe the most current SOC into usual care, specifically for: (a) offloading; (b) vascular assessment; and (c) debridement.
- Standard of Care Adherence52 Weeks
Proportion of participants who adhere to physician-prescribed SOC therapies for their DFU care.