DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Launched by UNIVERSITY OF MICHIGAN · Oct 23, 2023

Keywords

ClinConnect Summary

The DFC 004 clinical trial is studying how certain biological markers can help identify diabetic foot ulcers (DFUs) that are more likely to heal compared to those that may not. The goal is to use these markers to make personalized treatment decisions for patients and improve future research on wound healing. This study is currently recruiting participants who are 18 years or older, have diabetes, and have an open foot ulcer. Participants will need to agree to attend scheduled visits and provide some samples for analysis.

If you decide to join the trial, you can expect to be closely monitored, and your condition will be assessed to help understand how well these markers work in predicting healing. However, certain individuals may not be eligible, such as those currently undergoing treatment for DFUs, those with severe foot issues like gangrene, or those with certain health conditions that could affect their safety in the study. Overall, this trial aims to enhance care for people with diabetic foot ulcers by using advanced testing methods.

Gender

ALL

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 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.