Foot Ulcer, DiabeticPhase 2NCT00318214
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
A Phase 2 study testing MRE0094 in people with Foot Ulcer, Diabetic and Diabetes Complications, run by Pfizer at 19 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. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 19 sitesUnited States
- Study dates
- Jun 2006to Feb 2008
- 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 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.
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 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Lehigh Valley Podiatry Associates
Allentown, Pennsylvania, 18104
Limb Salvage Center
Dallas, Texas, 75231
Diabetic Foot & Wound Center
Denver, Colorado, 80220
UNC Wound Care Clinic
Durham, North Carolina, 27713
Roy O. Kroeker, DPM
Fresno, California, 93710
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834
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
Lubbock, Texas, 79410
University of Miami
Miami, Florida, 33136
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
North American Center for Limb Preservation
New Haven, Connecticut, 06515
Northern Michigan Hospital
Petoskey, Michigan, 49770
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015
North Shore Podiatry Group
Port Jefferson Station, New York, 11776
Calvary Hospital
The Bronx, New York, 10461
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
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
- Being tested
- MRE0094, Vehicle gel
- 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
Gel, 500 mcg/g once each day
Vehicle gelDrug
Gel administered once per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MRE0094 |
| 2 | Placebo comparator | Not described Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Measured: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
Measured: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
Measured: From baseline to the various treatment visits
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.
Measured: 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
Measured: At endpoint or 90 days, whichever is earlier
Time to closure and percent reduction in surface area of the target ulcer.
Measured: From baseline (Day 1) to the various treatment visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L. Rolleri, Pharm.D., Study director, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318214
- Sponsor's protocol ID
- MRE0094P-202
- Status last verified
- May 2012
- First submitted
- 24 Apr 2006
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- 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 Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00318214
- Acronym / sponsor ID
- MRE0094P-202
- 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
- TerminatedReason stopped: The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 26 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MRE0094 |
| 2 | Placebo comparator | Drug: Vehicle gel |
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 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| MRE0094Gel, 500 mcg/g once each day | Drug | 1 |
| Vehicle gelGel administered once per day | Drug | 2 |
Primary outcome
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Time frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
Time frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
Time frame: From baseline to the various treatment visits
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)
2 secondary outcomes
Incidence of complete healing of target ulcer
Time frame: At endpoint or 90 days, whichever is earlier
Time to closure and percent reduction in surface area of the target ulcer.
Time frame: From baseline (Day 1) to the various treatment visits
Results and safety
The study was stopped early (reason given: The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.). Results are not available in the source record.
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.
Robert L. Rolleri, Pharm.D. study director
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
19 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 19 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: stopped early, 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 19 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.). Results are not available in the source record.
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?
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094. (time frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier). The study lists 4 primary outcomes in all. 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.