Foot Ulcer, DiabeticPhase 2NCT00312364
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
A Phase 2 study testing MRE0094 in people with Foot Ulcer, Diabetic and Diabetes Complications, run by Pfizer at 63 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Foot Ulcer, Diabetic, Diabetes Complications
- What is being tested?
- MRE0094
- How many people
- 322 participants
- Where
- 63 sitesUnited States
- Study dates
- Dec 2005to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Lehigh Valley Podiatry Associates
Allentown, Pennsylvania, 18104
Advanced Regional Center for Ankle and Foot Care
Altoona, Pennsylvania, 16602
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103
Austintown Podiatry Associates, Inc.
Austintown, Ohio, 44515
Vertex Clinical Research
Bakersfield, California, 93311
Dolby Research, LLC
Baton Rouge, Louisiana, 70809
Bone, Spine, Sports Center
Bismarck, North Dakota, 58501
Podiatry Center of Idaho, PLLC
Boise, Idaho, 83713
Richard G. Seegmiller, DPM
Bountiful, Utah, 84010
Palo Verde Foot and Ankle
Bullhead City, Arizona, 86442
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Countryside Foot and Ankle Center
Clearwater, Florida, 33763
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Optimed Research, LLC
Columbus, Ohio, 43235
Prigoff-Bowers, LLP
Dallas, Texas, 75224
Limb Salvage Center
Dallas, Texas, 75231
Diabetic Foot & Wound Center
Denver, Colorado, 80220
UNC Wound Care Clinic
Durham, North Carolina, 27713
St. John's Queens Hospital
Elmhurst, New York, 11373
Welborn Clinic
Evansville, Indiana, 47713
UPMC Horizon
Farrell, Pennsylvania, 16121
South Texas Foot Institute
Floresville, Texas, 78114
Roy O. Kroeker, DPM
Fresno, California, 93710
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Adam S. Landsman, DPM, PhD, FACFAS
Highland Park, Illinois, 60035
Memorial Hermann Wound Center
Houston, Texas, 77030
Karr Foot & Leg Centers
Lakeland, Florida, 33813
Ankle and Foot Specialist of Atlanta
Lithonia, Georgia, 30058
Foot Healthcare Associates
Livonia, Michigan, 48152
Innovative Medical Technologies
Los Angeles, California, 90063
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
University of Miami
Miami, Florida, 33136
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
North American Center for Limb Preservation
New Haven, Connecticut, 06515
Advocate Lutheran General Hospital
Niles, Illinois, 60714
North Chicago VA Medical Center
North Chicago, Illinois, 60064
Baptist Hospital
Pensacola, Florida, 32501
Thomas Kevin Brattain, DPM
Peoria, Illinois, 61614
Northern Michigan Hospital
Petoskey, Michigan, 49770
Foot and Ankle Institute
Philadelphia, Pennsylvania, 19107
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015
North Shore Podiatry Group
Port Jefferson Station, New York, 11776
Douglas C. Flegal, DMP, FACFAS
Salt Lake City, Utah, 48103
Barrett Quality Medical Interests, LP
San Antonio, Texas, 78216
San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229
UCSD Wound Treatment and Research Center
San Diego, California, 92103
Bay Area Foot Care
San Francisco, California, 94115
Walter F. D'Costa, DPM
Santa Rosa, California, 95403
Doctor's Research Network
South Miami, Florida, 33143
Madigan Army Medical Center
Tacoma, Washington, 98431-1100
Dr. Robert J. Snyder
Tamarac, Florida, 33321
The Wound Healing Center
Terre Haute, Indiana, 47807
Calvary Hospital
The Bronx, New York, 10461
Aung Foot Health Clinics & Advanced Wound Care
Tucson, Arizona, 85710
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Foot & Ankle Physicians
Union, New Jersey, 07083
Carle Foundation Hospital
Urbana, Illinois, 61801
Atlantic Foot & Ankle Center
Virginia Beach, Virginia, 23454
Upstate Clinical Research Associates
Williamsville, New York, 14221
Christiana Care Health Systems Wound Care Center
Wilmington, Delaware, 19802
About this study
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.
- Conditions
- Foot Ulcer, Diabetic, Diabetes Complications
- Being tested
- MRE0094
- Keywords
- toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes
- Medical subject headings
- Diabetic Foot, Diabetes Complications, digital ulcers, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRE0094Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary outcomes (2)
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312364
- Sponsor's protocol ID
- MRE0094P-201
- Status last verified
- May 2012
- First submitted
- 6 Apr 2006
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00312364
- Acronym / sponsor ID
- MRE0094P-201
- Conditions
- Foot Ulcer, Diabetic, Diabetes Complications
- Keywords
- toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRE0094 | Drug | – |
Primary outcome
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
2 secondary outcomes
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRE0094 in people with Foot Ulcer, Diabetic and Diabetes Complications, run by Pfizer at 63 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.