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Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

Primary Purpose

Foot Ulcer, Diabetic, Diabetes Complications

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRE0094
Vehicle gel
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
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 a large ulcer or multiple ulcers 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 an off-loading device during the study to take pressure off the ulcer. They have certain other diseases, or are using certain types of drugs.

Sites / Locations

  • Associated Foot & Ankle Specialists, LLC
  • Southern Arizona VA Health Care System
  • Roy O. Kroeker, DPM
  • Innovative Medical Technologies
  • Diabetic Foot & Wound Center
  • North American Center for Limb Preservation
  • Karr Foot & Leg Centers
  • University of Miami
  • Ankle and Foot Specialist of Atlanta
  • Foot Healthcare Associates
  • Northern Michigan Hospital
  • Calvary Hospital
  • North Shore Podiatry Group
  • UNC Wound Care Clinic
  • Eastern Carolina Foot & Ankle Specialists
  • Lehigh Valley Podiatry Associates
  • Limb Salvage Center
  • Southwest Regional Wound Care
  • St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Incidence, intensity, and seriousness of adverse events (AEs).
Changes in irritation scores.
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.

Secondary Outcome Measures

Incidence of complete healing of target ulcer
Time to closure and percent reduction in surface area of the target ulcer.

Full Information

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

Unique Protocol Identification Number
NCT00318214
Brief Title
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

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. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors. Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MRE0094
Intervention Description
Gel, 500 mcg/g once each day
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Intervention Description
Gel administered once per day
Primary Outcome Measure Information:
Title
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Time Frame
Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Title
Incidence, intensity, and seriousness of adverse events (AEs).
Time Frame
Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Title
Changes in irritation scores.
Time Frame
From baseline to the various treatment visits
Title
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.
Time Frame
Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)
Secondary Outcome Measure Information:
Title
Incidence of complete healing of target ulcer
Time Frame
At endpoint or 90 days, whichever is earlier
Title
Time to closure and percent reduction in surface area of the target ulcer.
Time Frame
From baseline (Day 1) to the various treatment visits

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 a large ulcer or multiple ulcers 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 an off-loading device during the study to take pressure off the ulcer. They have certain other diseases, or are using certain types of drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Rolleri, Pharm.D.
Organizational Affiliation
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Associated Foot & Ankle Specialists, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
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
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
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
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
Ankle and Foot Specialist of Atlanta
City
Lithonia
State/Province
Georgia
ZIP/Postal Code
30058
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
Calvary Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
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
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
Lehigh Valley Podiatry Associates
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Limb Salvage Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Southwest Regional Wound Care
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
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

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Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

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