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

24. maj 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

322

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2005

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

6. april 2006

Først indsendt, der opfyldte QC-kriterier

6. april 2006

Først opslået (Skøn)

10. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2012

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MRE0094P-201

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes komplikationer

Kliniske forsøg med MRE0094

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner