SIU School of Medicine

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A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of Intramuscular Injection of Human Placenta-derived Cells (PDA-002) in Subjects with Peripheral Arterial Disease and Diabetic Foot Ulcer

IRB Number

13-763

ClinicalTrials.gov Identifier

NCT01859117

Trial Status

Open for Enrollment
Phase 1

Why is this study being done?

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.

Who is eligible to participate?

Patients with diabetic foot ulcers

What is involved?

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.

How long is the study?

Subjects will participate for approximately 24 months.

Who can I contact for additional information?

You may contact Tiffany Whitaker, RN at 217.545.2531 or twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Kim Hodgson, MD

Where is the trial located?

Springfield, Illinois