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

Purpose

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.

Condition	Intervention	Phase
Foot Ulcer, Diabetic Diabetes Complications	Drug: MRE0094 Drug: Vehicle gel	Phase II

MedlinePlus related topics:

Diabetes Diabetes Complications Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Further study details as provided by King Pharmaceuticals Research and Development:

Primary Outcome Measures:

Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094. [ Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: Yes ]
Incidence, intensity, and seriousness of adverse events (AEs). [ Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: Yes ]
Changes in irritation scores. [ Time Frame: From baseline to the various treatment visits ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of complete healing of target ulcer [ Time Frame: At endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: No ]
Time to closure and percent reduction in surface area of the target ulcer. [ Time Frame: From baseline (Day 1) to the various treatment visits ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	June 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MRE0094 Gel, 500 mcg/g once each day
2: Placebo Comparator	Drug: Vehicle gel Gel administered once per day

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318214

Locations


United States, Arizona
	Associated Foot & Ankle Specialists, LLC
	Phoenix, Arizona, United States, 85015
	Southern Arizona VA Health Care System
	Tucson, Arizona, United States, 85723

United States, California
	Innovative Medical Technologies
	Los Angeles, California, United States, 90063
	Roy O. Kroeker, DPM
	Fresno, California, United States, 93710

United States, Colorado
	Diabetic Foot & Wound Center
	Denver, Colorado, United States, 80220

United States, Connecticut
	North American Center for Limb Preservation
	New Haven, Connecticut, United States, 06515

United States, Florida
	Karr Foot & Leg Centers
	Lakeland, Florida, United States, 33813
	University of Miami
	Miami, Florida, United States, 33136

United States, Georgia
	Ankle and Foot Specialist of Atlanta
	Lithonia, Georgia, United States, 30058

United States, Michigan
	Foot Healthcare Associates
	Livonia, Michigan, United States, 48152
	Northern Michigan Hospital
	Petoskey, Michigan, United States, 49770

United States, New York
	Calvary Hospital
	Bronx, New York, United States, 10461
	North Shore Podiatry Group
	Port Jefferson Station, New York, United States, 11776

United States, North Carolina
	Eastern Carolina Foot & Ankle Specialists
	Greenville, North Carolina, United States, 27834
	UNC Wound Care Clinic
	Durham, North Carolina, United States, 27713

United States, Pennsylvania
	Lehigh Valley Podiatry Associates
	Allentown, Pennsylvania, United States, 18104

United States, Texas
	Limb Salvage Center
	Dallas, Texas, United States, 75231
	Southwest Regional Wound Care
	Lubbock, Texas, United States, 79410

United States, Wisconsin
	St. Luke's Medical Center
	Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

King Pharmaceuticals Research and Development

Investigators


Study Director:	Robert L. Rolleri, Pharm.D.	King Pharmaceuticals

More Information

Responsible Party:	King Pharmaceuticals, Inc. ( Eric G. Carter, Ph.D., M.D., Chief Science Officer )
Study ID Numbers:	MRE0094P-202
First Received:	April 24, 2006
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00318214
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Pharmaceuticals Research and Development:

toe ulcer

heel ulcer

foot ulcer

diabetic feet

diabetic foot

complications of diabetes

Study placed in the following topic categories:

Foot Ulcer

Skin Diseases

Diabetic Neuropathies

Ulcer

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Foot Diseases

Diabetic Angiopathies

Endocrinopathy

Skin Ulcer

Diabetes Complications

Diabetic Foot

Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	King Pharmaceuticals Research and Development
Information provided by:	King Pharmaceuticals Research and Development
ClinicalTrials.gov Identifier:	NCT00318214