Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
This study has been terminated.
(The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00318214
First received: April 24, 2006
Last updated: May 24, 2012
Last verified: May 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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 |
|---|---|
| Experimental: 1 |
Drug: MRE0094
Gel, 500 mcg/g once each day
|
| Placebo Comparator: 2 |
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 | |
| Roy O. Kroeker, DPM | |
| Fresno, California, United States, 93710 | |
| Innovative Medical Technologies | |
| Los Angeles, California, United States, 90063 | |
| 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 | |
| UNC Wound Care Clinic | |
| Durham, North Carolina, United States, 27713 | |
| Eastern Carolina Foot & Ankle Specialists | |
| Greenville, North Carolina, United States, 27834 | |
| 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
Pfizer
Investigators
| Study Director: | Robert L. Rolleri, Pharm.D. | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00318214 History of Changes |
| Other Study ID Numbers: | MRE0094P-202 |
| Study First Received: | April 24, 2006 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
toe ulcer heel ulcer foot ulcer |
diabetic feet diabetic foot complications of diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Ulcer Foot Ulcer Diabetic Foot Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes |
Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 19, 2013