Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.

Condition	Treatment or Intervention	Phase
Ulcer, Diabetic Foot	Drug: Piperacillin/Tazobactam	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Patients with diabetes mellitus
• Inpatient
• Adult
• Written informed consent
• Have 1 or more infected ulcer(s) below the ankle

Exclusion Criteria

• Must not have gangrene or severely impaired arterial supply in your foot
• Must not have a bone infection in the area of your ulcer
• Must not have allergies to penicillins
• Must not be pregnant or lactating

Alabama
      Research Site, Montgomery,  Alabama,  36106,  United States
Arizona
      Research Site, Phoenix,  Arizona,  85012,  United States
California
      Research Site, Monterey Park,  California,  91754,  United States
      Research Site, Orange,  California,  92868,  United States
      Research Site, Santa Rosa,  California,  95403,  United States
Connecticut
      Research Site, Stamford,  Connecticut,  06902,  United States
Florida
      Research Site, Atlantis,  Florida,  33462,  United States
      Research Site, Boca Raton,  Florida,  33486,  United States
      Research Site, Hollywood,  Florida,  33021,  United States
      Research Site, Lakeland,  Florida,  33813,  United States
      Research Site, Miami Beach,  Florida,  33139,  United States
      Research Site, Orlando,  Florida,  32806,  United States
Georgia
      Research Site, Blairsville,  Georgia,  30514,  United States
Hawaii
      Research Site, Honolulu,  Hawaii,  96814,  United States
Illinois
      Research Site, Moline,  Illinois,  61265,  United States
      Research Site, Springfield,  Illinois,  62701,  United States
Iowa
      Research Site, Des Moines,  Iowa,  50309,  United States
Kansas
      Research Site, Wichita,  Kansas,  62714,  United States
Louisiana
      Research Site, Covington,  Louisiana,  70433,  United States
      Research Site, New Orleans,  Louisiana,  70115,  United States
Maryland
      Research Site, Baltimore,  Maryland,  21201,  United States
Michigan
      Research Site, Royal Oak,  Michigan,  48073,  United States
Nebraska
      Research Site, Omaha,  Nebraska,  68105,  United States
New Jersey
      Research Site, Belleville,  New Jersey,  07109,  United States
      Research Site, Emerson,  New Jersey,  07630,  United States
      Research Site, Morristown,  New Jersey,  07962,  United States
      Research Site, Somers Point,  New Jersey,  08244,  United States
New York
      Research Site, Buffalo,  New York,  14215,  United States
      Research Site, Flushing,  New York,  11366,  United States
      Research Site, New York,  New York,  10003,  United States
      Research Site, New York,  New York,  10029,  United States
      Research Site, Poughkeepsie,  New York,  12601,  United States
Ohio
      Research Site, Akron,  Ohio,  44304,  United States
      Research Site, Zanesville,  Ohio,  43701,  United States
Pennsylvania
      Research Site, Hershey,  Pennsylvania,  17033,  United States
      Research Site, Philadelphia,  Pennsylvania,  19140,  United States
      Research Site, Pittsburgh,  Pennsylvania,  15224,  United States
Rhode Island
      Research Site, Providence,  Rhode Island,  02908,  United States
Tennessee
      Research Site, Copperhill,  Tennessee,  37317,  United States
      Research Site, Nashville,  Tennessee,  37203,  United States
Texas
      Research Site, Corpus Christi,  Texas,  78404,  United States
      Research Site, Dallas,  Texas,  75080,  United States
      Research Site, Dallas,  Texas,  75231,  United States
      Research Site, San Antonio,  Texas,  78207,  United States
      Research Site, San Antonio,  Texas,  78229,  United States
Virginia
      Research Site, Hampton,  Virginia,  23666,  United States
Washington
      Research Site, Seattle,  Washington,  98108,  United States

Study ID Numbers:  0910X-100468-US
Record last reviewed:  January 2003
Last Updated:  October 13, 2004
Record first received:  September 4, 2002
ClinicalTrials.gov Identifier:  NCT00044746
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08