University of Michigan
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
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 The platform study is designed to be flexible so that it is suitable for a wide range of studies relevant to patients with open (active) DFUs. This platform study will enroll patients with DFUs seen in an outpatient setting in diabetic foot and wound care cl…
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 clini…