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  • 1. North American Center For Limb Preservation Peter Blume, DPM FACFAS Jonathan Key, DPM AACFAS Michael G. Palladino, DPM FACFAS Clinical Research Studies
  • 2. A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE STUDY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SUBLACTAM (UNASYN) OR AMOXICILLIN-CLAVULANATE (AUGMENTIN) TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS. (WYETH, PROTOCOL 3074A1-900 SPONSOR: WYETH PHARMACEUTICALS, INC. Global Medical Affairs PO Box 8299 Philadelphia, PA 19101 CRO: Neddie Zadeikis, MD MBA QUINTILES 445 E. North Water Street #1304 Chicago, IL 60611 312-955-0414
  • 3. <ul><li>AN OPEN LABEL, THREE ARM, PILOT STUDY OF THE SAFETY AND CLINICAL EFFICACY OF TOPICAL DERMACYN WOUND CARE VS. ORAL LEVOFLOXACIN VS. COMBINED THERAPY FOR MILD DIABETIC FOOT INFECTIONS (OCCULUS INNOVATIVE SCIENCES, INC.,IND#: 67185 </li></ul><ul><li>SPONSOR: OCULUS INNOVATIVE SCIENCES, INC. </li></ul><ul><li>1129 McDowell Boulevard </li></ul><ul><li>Petaluma, CA 94954 </li></ul><ul><li>OCULUS CONTACT: Andres Gutierrez, MD, PhD </li></ul><ul><li>707-559-7230 </li></ul><ul><li>CRO: PPD </li></ul><ul><li>3151 South 17 th Street </li></ul><ul><li>Wilmington, NC 28412-6461 </li></ul><ul><li>PPD CONTACT: Gina Balogh </li></ul><ul><li>215-591-6644 </li></ul>
  • 4. LINEZOLID IN THE TREATMENT OF SUBJECTS WITH COMPLICATED SKIN AND SOFT TISSUE INFECTIONS PROVEN TO BE DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. (PFIZER, ROTOCOL:A5951002) SPONSOR: PFIZER PHARMACEUTICALS New York Headquarters 235 East 42 Street New York, NY 10017 PFIZER CONTACT: Meryl Mendelson, MD 212-733-4923 CRO: COVANCE PERIAPPROVAL SERVICES, INC. One Radnor Corporate Center Radnor, PA 19087 610-687-5454
  • 5. A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF CARDIOVASCULAR SAFETY IN OSTEOARTHRITIS OR RHEUMATOID ARTHRTIS PATIENTS WITH OR AT HIGH RISK FOR CARDIOVASCULAR DISEASE COMPARING CELECOXIB WITH NAPROXEN AND IBUPROFEN (PFIZER, PROTOCOL A3191172 ) SPONSOR: PFIZER PHARMACEUTICALS, INC. 235 East 42 nd Street New York, NY 10017-5755 CRO: QUINTILES, INC. 6700 West 115 th Street, 307B Overland Park, KS 66211 CRO CONTACT: Stacy Baker 913-708-6212
  • 6. EFFECT OF DAPTOMYCIN ON HEALING OF ACUTE AND CHRONIC FOOT WOUNDS – AN ANALYSIS OF WOUND FLUIDS (CUBIST, A PILOT STUDY) SPONSOR: CUBIST PHARMACEUTICALS, INC. 65 HAYDEN AVENUE LEXINGTON, MA02421 CUBIST CONTACT: Nayiri Baljian 781-860-8403
  • 7. A PHASE II, DOUBLE-BLINDED, RANDOMIZED, PLACEBO- CONTROLLED STUDY TO ASSESS THE EFFECT OF TOPICAL RECOMBINANT HUMAN VASCULAR ENDOTHELIAL GROWTH FACTOR (TELBERMIN) FOR INDUCTION OF HEALING OF DIABETIC FOOT ULCERS (GENENTECH, INC. PROTOCOL VGF3554g) SPONSOR: GENENTECH, INC. 1 DNA Way South San Francisco, CA 94080 MEDICAL MONITOR: Paul Kwon, MD 650-467-8863 CRO: PPD 3151 South 17 th Street Wilmington, NC 28412-6461 PPD PROJECT MANAGER: Jessica Chaparro 910-251-0081
  • 8. A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, VEHICLE AND STANDARD CARE-CONTROLLED, DOSE-RANGING STUDY ASSESSING THE SAFETY AND EFFICACY OF MRE0094 GEL WHEN APPLIED TOPICALLY FOR 90 DAYS TO SUBJECTS WITH DIABETIC, NEUROTROPHIC, FOOT ULCERS (KING PHARMACEUTICAL RESEARCH AND DEVELOPMENT, INC., PROTOCOL: MRE0094P-201; MRE0094P-202). SPONSOR: KING PHARMACEUTICALS, INC. 4000 CentreGreen Way, Suite 300 Cary, NC 27513 MEDICAL MONITOR: Charles L. Pamplin III, MD 919-653-7042 CRO: RESEARCH POINT 1301 S. Mopac Expressway Suite 50 Austin, TX 78746 CRO CONTACT: Melissa Conroy 512-343-1092
  • 9. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND DOUBLE-DOSE, COMPARATOR ARM (STANDARD OF CARE), MULTICENTER PHASE 2b STUDY OF TOPICAL GAM501 (Ad5PDGF-B/BOVINE TYPE I COLLAGEN GEL) IN THE TREATMENT OF NON-HEALING DIABETIC ULCERS OF THE LOWER EXTREMITY. (TISSUE REPAIR COMPANY) SPONSOR: TISSUE REPAIR COMPANY 11545 Sorrento Valley Road Suite 310 San Diego, CA 92121 CONSULTANT: Symanthis Robertson, MS CCRA 919-789-4536
  • 10. A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF VACUUM ASSISTED CLOSURE (V.A.C.) THERAPY IN THE TREATMENT AND BLINDED EVALUATION OF DIABETIC FOOT ULCERS. (KINETIC CONCEPTS,INC., PROTOCOL:VAC2001-08) SPONSOR: KCI, USA Inc. 8023 Vantage Drive San Antonio, TX 78265 CLINICAL RESEARCH DIRECTOR: Stacey Pugh, RN BSN 210-255-6176 CLINICAL TRIALS COORDINATOR: Kerry Couder 210-255-6660 CLINICAL RESEARCH ASSOCIATE: Rayma Dorris 210-255-6798
  • 11. THE USE OF V.A.C. NEGATIVE PRESSURE WOUND THERAPY (NPWT) ON DIABETIC FOOT AMPUTATION WOUNDS (KINETIC CONCEPTS, INC., PROTOCOL:VAC2006-19) SPONSOR: KCI USA, INC. 8023 Vantage Drive San Antonio, TX 78265 KCI MANAGEMENT MONITOR: Diana Sanchez-Garcia, MBA, RN 800-531-5396 x56661 PRIMARY LEAD INVESTIGATOR: Peter Blume, DPM FACFAS 203-397-0624
  • 12. DETERMINATION OF APPROPRIATE WOUND FLUID COLLECTION AND ANALYSIS METHODS ( KINETIC CONCEPTS, INC., PILOT STUDY, PROTOCOL VACP2006-09) SPONSOR: KCI USA, INC. 8023 Vantage Drive San Antonio, TX 78230 PROJECT MANAGER: Corey Eisenberg 210-255-6713
  • 13. A RANDOMIZED CONTROLLED STUDY COMPARING METABOLITES AND PROTEIN MARKERS IN ACUTE FOOT AMPUTATIONS TREATED WITH V.A.C. THERAPY IN EITHER CONTINUOUS OR INTERMITTANT MODE AND MOIST WOUND THERAPY (KINETIC CONCEPTS, INS.,PROTOCOL: VACP2006-02) SPONSOR: KCI USA, INC. 8023 Vantage Drive San Antonio, TX 78230 KCI MANAGEMENT MONITOR: Katherine Carey, BSN RN 800-531.5396 x56156 PRIMARY LEAD INVESTIGATOR: Peter Blume, DPM FACFAS 203-397-0624

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