The purpose of this study is to test the safety of PDA-002 at different dose levels. We want to find out what effects, good and/or bad, it has on you and your diabetic foot ulcers.
Patients with diabetic foot ulcers
There are 10 visits spread over 24 months of study participation. Study drug is administered at two different clinic visits approximately 1 week apart. The study drug is injected at 15 different locations on the study leg between the knee and foot at each of the two treatment visits. Follow-up visits are performed at two weeks,one month, 3 months, 6 months 9 months, 12 months and 24 months after the initial treatment. Leg and foot wounds are measured and photographed at each study visit. Patients undergo multiple blood and urine tests. MRI or CT scans are performed, at the sponsor's expense, at the screening, 12 month and 24 month visits. Retinal exams, at the sponsor's expense, are performed at screening and the 6 month visit.
Subjects will participate for approximately 24 months.
You may contact Tiffany Whitaker, RN at 217.545.2531 or firstname.lastname@example.org
Kim Hodgson, MD