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

Primary Purpose

Foot Ulcer, Diabetic, Diabetes Complications

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRE0094
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic focused on measuring toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Advanced Wound Care
  • Palo Verde Foot and Ankle
  • Carl T. Hayden VA Medical Center
  • Associated Foot & Ankle Specialists, LLC
  • Aung Foot Health Clinics & Advanced Wound Care
  • Southern Arizona VA Health Care System
  • Vertex Clinical Research
  • Roy O. Kroeker, DPM
  • Innovative Medical Technologies
  • UCSD Wound Treatment and Research Center
  • Bay Area Foot Care
  • Walter F. D'Costa, DPM
  • Diabetic Foot & Wound Center
  • North American Center for Limb Preservation
  • Christiana Care Health Systems Wound Care Center
  • Countryside Foot and Ankle Center
  • Karr Foot & Leg Centers
  • University of Miami
  • Baptist Hospital
  • Doctor's Research Network
  • Dr. Robert J. Snyder
  • Ankle and Foot Specialist of Atlanta
  • Podiatry Center of Idaho, PLLC
  • Adam S. Landsman, DPM, PhD, FACFAS
  • Advocate Lutheran General Hospital
  • North Chicago VA Medical Center
  • Thomas Kevin Brattain, DPM
  • Carle Foundation Hospital
  • Welborn Clinic
  • The Wound Healing Center
  • Dolby Research, LLC
  • David Fivenson, MD, Dermatology, PLLC
  • Foot Healthcare Associates
  • Northern Michigan Hospital
  • Foot & Ankle Physicians
  • Calvary Hospital
  • St. John's Queens Hospital
  • North Shore Podiatry Group
  • Upstate Clinical Research Associates
  • UNC Wound Care Clinic
  • Eastern Carolina Foot & Ankle Specialists
  • Bone, Spine, Sports Center
  • Austintown Podiatry Associates, Inc.
  • New Horizons Clinical Research
  • Cleveland Clinic Foundation
  • Optimed Research, LLC
  • Lehigh Valley Podiatry Associates
  • Advanced Regional Center for Ankle and Foot Care
  • UPMC Horizon
  • Penn State Milton S. Hershey Medical Center
  • Foot and Ankle Institute
  • Prigoff-Bowers, LLP
  • Limb Salvage Center
  • South Texas Foot Institute
  • Memorial Hermann Wound Center
  • Southwest Regional Wound Care Center
  • Barrett Quality Medical Interests, LP
  • San Antonio Podiatry Associates, PC
  • Richard G. Seegmiller, DPM
  • Douglas C. Flegal, DMP, FACFAS
  • Atlantic Foot & Ankle Center
  • Madigan Army Medical Center
  • St. Luke's Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2006
Last Updated
May 24, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00312364
Brief Title
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic, Diabetes Complications
Keywords
toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MRE0094
Primary Outcome Measure Information:
Title
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary Outcome Measure Information:
Title
Time to closure and percent reduction in surface area of the target ulcer.
Title
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Palo Verde Foot and Ankle
City
Bullhead City
State/Province
Arizona
ZIP/Postal Code
86442
Country
United States
Facility Name
Carl T. Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Associated Foot & Ankle Specialists, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Aung Foot Health Clinics & Advanced Wound Care
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Vertex Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Roy O. Kroeker, DPM
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Innovative Medical Technologies
City
Los Angeles
State/Province
California
ZIP/Postal Code
90063
Country
United States
Facility Name
UCSD Wound Treatment and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Bay Area Foot Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Walter F. D'Costa, DPM
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Diabetic Foot & Wound Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
North American Center for Limb Preservation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Christiana Care Health Systems Wound Care Center
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19802
Country
United States
Facility Name
Countryside Foot and Ankle Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33763
Country
United States
Facility Name
Karr Foot & Leg Centers
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33813
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Doctor's Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Dr. Robert J. Snyder
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Ankle and Foot Specialist of Atlanta
City
Lithonia
State/Province
Georgia
ZIP/Postal Code
30058
Country
United States
Facility Name
Podiatry Center of Idaho, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Adam S. Landsman, DPM, PhD, FACFAS
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
North Chicago VA Medical Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Thomas Kevin Brattain, DPM
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
The Wound Healing Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47807
Country
United States
Facility Name
Dolby Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
David Fivenson, MD, Dermatology, PLLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Foot Healthcare Associates
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Foot & Ankle Physicians
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Facility Name
Calvary Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
St. John's Queens Hospital
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
North Shore Podiatry Group
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
UNC Wound Care Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Eastern Carolina Foot & Ankle Specialists
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Bone, Spine, Sports Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Austintown Podiatry Associates, Inc.
City
Austintown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Optimed Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Lehigh Valley Podiatry Associates
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Advanced Regional Center for Ankle and Foot Care
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
UPMC Horizon
City
Farrell
State/Province
Pennsylvania
ZIP/Postal Code
16121
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Foot and Ankle Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Prigoff-Bowers, LLP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Limb Salvage Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
South Texas Foot Institute
City
Floresville
State/Province
Texas
ZIP/Postal Code
78114
Country
United States
Facility Name
Memorial Hermann Wound Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Barrett Quality Medical Interests, LP
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78216
Country
United States
Facility Name
San Antonio Podiatry Associates, PC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Richard G. Seegmiller, DPM
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Douglas C. Flegal, DMP, FACFAS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
48103
Country
United States
Facility Name
Atlantic Foot & Ankle Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-1100
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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