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Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

24. mai 2012 oppdatert av: Pfizer

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.

Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.

Participation in the study can be up to 4½ months.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Legemiddel: MRE0094

Studietype

Intervensjonell

Registrering (Faktiske)

322

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alabama
  - Montgomery, Alabama, Forente stater, 36111
    - Institute for Advanced Wound Care
- Arizona
  - Bullhead City, Arizona, Forente stater, 86442
    - Palo Verde Foot and Ankle
  - Phoenix, Arizona, Forente stater, 85012
    - Carl T. Hayden VA Medical Center
  - Phoenix, Arizona, Forente stater, 85015
    - Associated Foot & Ankle Specialists, LLC
  - Tucson, Arizona, Forente stater, 85723
    - Southern Arizona VA Health Care System
  - Tucson, Arizona, Forente stater, 85710
    - Aung Foot Health Clinics & Advanced Wound Care
- California
  - Bakersfield, California, Forente stater, 93311
    - Vertex Clinical Research
  - Fresno, California, Forente stater, 93710
    - Roy O. Kroeker, DPM
  - Los Angeles, California, Forente stater, 90063
    - Innovative Medical Technologies
  - San Diego, California, Forente stater, 92103
    - UCSD Wound Treatment and Research Center
  - San Francisco, California, Forente stater, 94115
    - Bay Area Foot Care
  - Santa Rosa, California, Forente stater, 95403
    - Walter F. D'Costa, DPM
- Colorado
  - Denver, Colorado, Forente stater, 80220
    - Diabetic Foot & Wound Center
- Connecticut
  - New Haven, Connecticut, Forente stater, 06515
    - North American Center for Limb Preservation
- Delaware
  - Wilmington, Delaware, Forente stater, 19802
    - Christiana Care Health Systems Wound Care Center
- Florida
  - Clearwater, Florida, Forente stater, 33763
    - Countryside Foot and Ankle Center
  - Lakeland, Florida, Forente stater, 33813
    - Karr Foot & Leg Centers
  - Miami, Florida, Forente stater, 33136
    - University of Miami
  - Pensacola, Florida, Forente stater, 32501
    - Baptist Hospital
  - South Miami, Florida, Forente stater, 33143
    - Doctor's Research Network
  - Tamarac, Florida, Forente stater, 33321
    - Dr. Robert J. Snyder
- Georgia
  - Lithonia, Georgia, Forente stater, 30058
    - Ankle and Foot Specialist of Atlanta
- Idaho
  - Boise, Idaho, Forente stater, 83713
    - Podiatry Center of Idaho, PLLC
- Illinois
  - Highland Park, Illinois, Forente stater, 60035
    - Adam S. Landsman, DPM, PhD, FACFAS
  - Niles, Illinois, Forente stater, 60714
    - Advocate Lutheran General Hospital
  - North Chicago, Illinois, Forente stater, 60064
    - North Chicago VA Medical Center
  - Peoria, Illinois, Forente stater, 61614
    - Thomas Kevin Brattain, DPM
  - Urbana, Illinois, Forente stater, 61801
    - Carle Foundation Hospital
- Indiana
  - Evansville, Indiana, Forente stater, 47713
    - Welborn Clinic
  - Terre Haute, Indiana, Forente stater, 47807
    - The Wound Healing Center
- Louisiana
  - Baton Rouge, Louisiana, Forente stater, 70809
    - Dolby Research, LLC
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48103
    - David Fivenson, MD, Dermatology, PLLC
  - Livonia, Michigan, Forente stater, 48152
    - Foot Healthcare Associates
  - Petoskey, Michigan, Forente stater, 49770
    - Northern Michigan Hospital
- New Jersey
  - Union, New Jersey, Forente stater, 07083
    - Foot & Ankle Physicians
- New York
  - Bronx, New York, Forente stater, 10461
    - Calvary Hospital
  - Elmhurst, New York, Forente stater, 11373
    - St. John's Queens Hospital
  - Port Jefferson Station, New York, Forente stater, 11776
    - North Shore Podiatry Group
  - Williamsville, New York, Forente stater, 14221
    - Upstate Clinical Research Associates
- North Carolina
  - Durham, North Carolina, Forente stater, 27713
    - UNC Wound Care Clinic
  - Greenville, North Carolina, Forente stater, 27834
    - Eastern Carolina Foot & Ankle Specialists
- North Dakota
  - Bismarck, North Dakota, Forente stater, 58501
    - Bone, Spine, Sports Center
- Ohio
  - Austintown, Ohio, Forente stater, 44515
    - Austintown Podiatry Associates, Inc.
  - Cincinnati, Ohio, Forente stater, 45242
    - New Horizons Clinical Research
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Foundation
  - Columbus, Ohio, Forente stater, 43235
    - Optimed Research, LLC
- Pennsylvania
  - Allentown, Pennsylvania, Forente stater, 18104
    - Lehigh Valley Podiatry Associates
  - Altoona, Pennsylvania, Forente stater, 16602
    - Advanced Regional Center for Ankle and Foot Care
  - Farrell, Pennsylvania, Forente stater, 16121
    - UPMC Horizon
  - Hershey, Pennsylvania, Forente stater, 17033
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forente stater, 19107
    - Foot and Ankle Institute
- Texas
  - Dallas, Texas, Forente stater, 75231
    - Limb Salvage Center
  - Dallas, Texas, Forente stater, 75224
    - Prigoff-Bowers, LLP
  - Floresville, Texas, Forente stater, 78114
    - South Texas Foot Institute
  - Houston, Texas, Forente stater, 77030
    - Memorial Hermann Wound Center
  - Lubbock, Texas, Forente stater, 79410
    - Southwest Regional Wound Care Center
  - San Antonio, Texas, Forente stater, 78216
    - Barrett Quality Medical Interests, LP
  - San Antonio, Texas, Forente stater, 78229
    - San Antonio Podiatry Associates, PC
- Utah
  - Bountiful, Utah, Forente stater, 84010
    - Richard G. Seegmiller, DPM
  - Salt Lake City, Utah, Forente stater, 48103
    - Douglas C. Flegal, DMP, FACFAS
- Virginia
  - Virginia Beach, Virginia, Forente stater, 23454
    - Atlantic Foot & Ankle Center
- Washington
  - Tacoma, Washington, Forente stater, 98431-1100
    - Madigan Army Medical Center
- Wisconsin
  - Milwaukee, Wisconsin, Forente stater, 53215
    - St. Luke's Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Participants included in the study must:

Have type 1 or type 2 diabetes mellitus.
Have problems with the nerves in their feet.
Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
Be able to apply study drug to their ulcer, or have a caregiver do it.
Be able to visit the doctor regularly during the 4½ month study.

Exclusion Criteria:

Participants may not participate in the study if:

Their ulcer is caused by bad blood flow to their foot.
Their ulcer is infected.
They cannot wear a special boot during the study to take pressure off the ulcer.
They have certain other diseases, or are using certain types of drugs.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Hva måler studien?

Primære resultatmål

Resultatmål
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.

Sekundære resultatmål

Resultatmål
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2005

Primær fullføring (Faktiske)

1. desember 2007

Studiet fullført (Faktiske)

1. desember 2007

Datoer for studieregistrering

Først innsendt

6. april 2006

Først innsendt som oppfylte QC-kriteriene