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Barry University’s School of Podiatric Medicine seeks diabetes patients with chronic ulcers for wound care clinical trial

Gladys Amador

(305) 899-4919

Miami Shores, Fla. – The Paul & Margaret Brand Research Center at Barry University’s School of Podiatric Medicine is searching for diabetes patients willing to participate in an investigational trial. The study will evaluate the effectiveness of a cell based therapy along with standard Good Ulcer Care (GUC) measures in treating foot ulcers in adults with diabetes mellitus. The goal is to evaluate the clinical benefit of this cell based therapy compared to a control therapy, which simulates an injection along with GUC treatments.

“As the incidence of diabetes increases around the globe and the complications of diabetic ulcers on the foot and ankle results in millions of lower extremity amputations, the need to treat and heal diabetic ulcers is critical to the reduction of amputations,” said Dr. Robert Snyder, principal investigator and clinical research director of the Paul & Margaret Brand Research Center at Barry University.

Barry’s study is part of a 375 patient, multinational, multicenter, randomized, double-blind study for patients between the ages of 18-80 with Diabetes Mellitus (Type 1 or 2) who have chronic lower extremity ulcers on or below the ankle and are to be treated with GUC.

The clinical trial will take place at Barry University’s Foot and Ankle Institute in Hialeah, FL (777 East 25th Street, Suite 316). A maximum of 15 patients will participate in the study for approximately 16-32 weeks.

Additional objectives of the study are to demonstrate safety, tolerability and durability of this cell based therapy compared to the control group as an adjunct to GUC. The study is blinded such that the clinical study staff, patients, and the principal investigator do not know what treatment assignment will be administered. There is an un-blinded treatment administrator who will not be involved in any other aspects of the study who will administer the assigned study treatment.

For more information or to enroll in the study, contact Maria Swartz, BS, CCRC, clinical research coordinator, Paul & Margaret Brand Research Center at Barry University, 777 East 25th Street, Suite 316, Hialeah, FL  33013. Phone: 305-836-7550, Fax: 305-694-9616, email mswartz@mail.barry.edu