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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Wound Healing — 52 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 Infections — 52 Weeks Proportion of participants who develop infections of the index DFU among those with no infections at baseline.
Amputations — 52 Weeks Proportion of participants who have an amputation of the limb associated with the index DFU.
Prediction Performance — 52 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 Count — 52 Weeks Proportion of eligible participants providing biospecimens by site, and by type (serum, plasma, wound fluid, wound dressings, wound debridement tissue, urine).
Biospecimen Quality — 52 Weeks Proportion of biospecimens of adequate quality by type.
Standard of Care Prescription by Site — 52 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 Adherence — 52 Weeks Proportion of participants who adhere to physician-prescribed SOC therapies for their DFU care.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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