Center for Drug Evaluation and Research




October 28, 2003


Holiday Inn, The Ballrooms, Two Montgomery Village Avenue, Gaithersburg, MD


Topic:  Clinical trial design in Diabetic Foot Infections



1:00 p.m.          Call to Order                                                                 James E. Leggett, Jr., M.D.

                                                                                                            Chair, AIDAC

                        Introduction of Committee


                        Conflict of Interest Statement                                         Tara P. Turner, Pharm. D.

                                                                                                            Executive Secretary, AIDAC


1:10 p.m.          Overview: Antimicrobial Development             Janice Soreth, MD

                        for Diabetic Foot Infections                                         Director

                                                                                                            Division of Anti-Infective Drug Products



1:20 p.m.          Diabetic Foot Infections: Overview                              Dr. Tony Berendt, BM, BCh, FRCP

                                                                                                            Bone Infection Unit

                                                                                                            Nuffield Orthopaedic Centre, Oxford, UK


1:40 p.m.          Clinical trials consideration in DM foot infections       Carl Norden, M.D.

                                                                                                            Medical Director

                                                                                                            Pfizer Inc.


2:00 p.m.          Lessons Learned from Previous Review                       Alfred Sorbello, D.O.

                        of Drugs for Diabetic Foot Infections                           Medical Officer

                                                                                                            Division of Anti-Infective Drug Products



2:20 p.m.          Microbiologic Diagnosis of Diabetic                            Albert Sheldon, Ph.D.

                        Foot Infections                                                            Microbiology Team Leader

                                                                                                            Division of Anti-Infective Drug Products



2:40 p.m.          Ruling Out Osteomyelitis in Trials of                           Regina Alivisatos, M.D.

                        Diabetic Foot Infections                                               Medical Officer

Division of Special Pathogen and

Immunologic Drug Products, FDA


3:00 p.m.          Implications for Clinical Trials                                    David Ross, M.D., Ph.D.

                        for Diabetic Foot Infections                                         Medical Team Leader

Division of Anti-Infective Drug Products



3:15 p.m.          Break




3:25 p.m.          Open Public Hearing


3:55 p.m.          Charge to the Committee                                                Edward Cox, M.D., M.P.H.                                                                                                                        Deputy Director

                                                                                                            Office of Drug Evaluation IV, FDA


4:00 p.m.          Committee Discussion


5:30 p.m.          Adjourn                                                                       









1.      How does one define a “diabetic foot infection”?  Please include in your discussions the considerations of patients with cellulitis without breaks in the skin versus patients with pre-existing breaks in the skin.


2.      In patients with a pre-existing skin ulcer, how does one define infected versus non-infected ulcers?


3.      What is the most accurate way to obtain microbiologic information in patients with diabetic foot infections?


4.      What are the considerations for clinical trials for ruling out osteomyelitis in patients in trials of diabetic foot infections?  Please discuss how to determine drug efficacy for the diabetic foot infection in the setting of osteomyelitis and whether such patients should be considered clinical cures or failures.


5.      How does one define clinical success or failure patients in a clinical trial of diabetic foot infections?