Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study.

STUDY BASICS

Have you been diagnosed with diabetes and have an open sore or wound on your foot? You may be eligible for a research study to learn more about diabetic foot ulcers and to evaluate the ability of specific biomarkers in your blood, wound tissue or urine. This may help predict an individual’s healing ability or if a healed diabetic foot ulcer is more likely to open. Compensation is provided.

STUDY PURPOSE

Some diabetic foot ulcers, heal within 12 weeks while others last much longer. Also, some healed diabetic foot ulcers reopen within months of closing. The purpose of this research is to assess the collection of blood, urine, wound dressings, and tissue from individuals with a diabetic foot ulcer to evaluate multiple biomarkers for predictability of the clinical outcome.

COULD THIS STUDY BE RIGHT FOR YOU?

• 18 years of age or older
• Diagnosed with diabetes
• Currently have an open foot ulcer (open sore or wound on your foot)

WHAT PARTICIPANTS CAN EXPECT

Baseline – Visit 1

• Consenting
• Questionnaires
• Physical measurement
• Collection of specimens
• Collection of pictures of the wound

Follow-up visits every other week for one month, then monthly thereafter.

• Questionnaires
• Collection of specimens