“Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers”
You are invited to take part in this research study because you have diabetes, are between the ages of eighteen (18) and eighty-nine (89) years old and have a diabetic foot ulcer (wound) for thirty (30) days or more. Your wound care provider has determined that you need treatment for this wound. This research is studying a powder wound dressing called Altrazeal® Transforming Powder (Altrazeal®) for treatment of diabetic foot ulcers. Altrazeal® is a powder that is sprinkled directly onto your foot ulcer, after your wound has been cleaned and is ready for a dressing. Altrazeal® is made from a substance (polymer) used to make soft contact lenses. The powder covers and protects the wound. It is designed to stay in place for up to 30 days. Altrazeal® is a Class-I medical device manufactured in the United States (U.S.) by a company that is registered with the United States Food and Drug Administration (FDA). It is currently being used at a number of U.S. and international health care facilities. Altrazeal® has been used on many types of wounds, including diabetic foot ulcers.
This study is currently enrolling.