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

NCT00318214 | Terminated Phase 2

• 1 other identifier: MRE0094P-202
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 19

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.

Conditions

Foot Ulcer, Diabetic; Diabetes Complications

Keywords

toe ulcer; heel ulcer; foot ulcer; diabetic feet; diabetic foot; complications of diabetes

Outcome Measures

Primary Outcomes (4)

• Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.

  Baseline (Day 1) to endpoint or 90 days, whichever is earlier

• Incidence, intensity, and seriousness of adverse events (AEs).

  Baseline (Day 1) to endpoint or 90 days, whichever is earlier

• Changes in irritation scores.

  From baseline to the various treatment visits

• Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.

  Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)

Secondary Outcomes (2)

• Incidence of complete healing of target ulcer

  At endpoint or 90 days, whichever is earlier

• Time to closure and percent reduction in surface area of the target ulcer.

  From baseline (Day 1) to the various treatment visits

Study Arms (2)

1

EXPERIMENTAL

Drug: MRE0094

2

PLACEBO COMPARATOR

Drug: Vehicle gel

Interventions

MRE0094 DRUG

Gel, 500 mcg/g once each day

1

Vehicle gel DRUG

Gel administered once per day

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Associated Foot & Ankle Specialists, LLC

Phoenix, Arizona, 85015, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Roy O. Kroeker, DPM

Fresno, California, 93710, United States

Location

Innovative Medical Technologies

Los Angeles, California, 90063, United States

Location

Diabetic Foot & Wound Center

Denver, Colorado, 80220, United States

Location

North American Center for Limb Preservation

New Haven, Connecticut, 06515, United States

Location

Karr Foot & Leg Centers

Lakeland, Florida, 33813, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Ankle and Foot Specialist of Atlanta

Lithonia, Georgia, 30058, United States

Location

Foot Healthcare Associates

Livonia, Michigan, 48152, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

North Shore Podiatry Group

Port Jefferson Station, New York, 11776, United States

Location

Calvary Hospital

The Bronx, New York, 10461, United States

Location

UNC Wound Care Clinic

Durham, North Carolina, 27713, United States

Location

Eastern Carolina Foot & Ankle Specialists

Greenville, North Carolina, 27834, United States

Location

Lehigh Valley Podiatry Associates

Allentown, Pennsylvania, 18104, United States

Location

Limb Salvage Center

Dallas, Texas, 75231, United States

Location

Southwest Regional Wound Care

Lubbock, Texas, 79410, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Complications; digital ulcers; Foot Ulcer

Interventions

2-(2-(4-chlorophenyl)ethoxy)adenosine

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Study Officials

• Robert L. Rolleri, Pharm.D.

  King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: June 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (19)