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

Sponsored by:	King Pharmaceuticals Research and Development
Information provided by:	King Pharmaceuticals Research and Development
ClinicalTrials.gov Identifier:	NCT00312364

Purpose

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.

Condition	Intervention	Phase
Foot Ulcer, Diabetic Diabetes Complications	Drug: MRE0094	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, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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.

Enrollment:	322
Study Start Date:	December 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312364

Show 63 Study Locations

Sponsors and Collaborators

King Pharmaceuticals Research and Development

More Information

Study ID Numbers:	MRE0094P-201
Study First Received:	April 6, 2006
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00312364
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 January 16, 2009