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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRE0094 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to closure and percent reduction in surface area of the target ulcer. | ||
| Incidence, intensity, and seriousness of adverse events. Changes in irritation scores. |
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Inclusion Criteria:
Participants included in the study must:
Exclusion Criteria:
Participants may not participate in the study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Advanced Wound Care | Montgomery | Alabama | 36111 | United States | ||
| Palo Verde Foot and Ankle |
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| Bullhead City |
| Arizona |
| 86442 |
| United States |
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | United States |
| Associated Foot & Ankle Specialists, LLC | Phoenix | Arizona | 85015 | United States |
| Aung Foot Health Clinics & Advanced Wound Care | Tucson | Arizona | 85710 | United States |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | United States |
| Vertex Clinical Research | Bakersfield | California | 93311 | United States |
| Roy O. Kroeker, DPM | Fresno | California | 93710 | United States |
| Innovative Medical Technologies | Los Angeles | California | 90063 | United States |
| UCSD Wound Treatment and Research Center | San Diego | California | 92103 | United States |
| Bay Area Foot Care | San Francisco | California | 94115 | United States |
| Walter F. D'Costa, DPM | Santa Rosa | California | 95403 | United States |
| Diabetic Foot & Wound Center | Denver | Colorado | 80220 | United States |
| North American Center for Limb Preservation | New Haven | Connecticut | 06515 | United States |
| Christiana Care Health Systems Wound Care Center | Wilmington | Delaware | 19802 | United States |
| Countryside Foot and Ankle Center | Clearwater | Florida | 33763 | United States |
| Karr Foot & Leg Centers | Lakeland | Florida | 33813 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Baptist Hospital | Pensacola | Florida | 32501 | United States |
| Doctor's Research Network | South Miami | Florida | 33143 | United States |
| Dr. Robert J. Snyder | Tamarac | Florida | 33321 | United States |
| Ankle and Foot Specialist of Atlanta | Lithonia | Georgia | 30058 | United States |
| Podiatry Center of Idaho, PLLC | Boise | Idaho | 83713 | United States |
| Adam S. Landsman, DPM, PhD, FACFAS | Highland Park | Illinois | 60035 | United States |
| Advocate Lutheran General Hospital | Niles | Illinois | 60714 | United States |
| North Chicago VA Medical Center | North Chicago | Illinois | 60064 | United States |
| Thomas Kevin Brattain, DPM | Peoria | Illinois | 61614 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Welborn Clinic | Evansville | Indiana | 47713 | United States |
| The Wound Healing Center | Terre Haute | Indiana | 47807 | United States |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | United States |
| David Fivenson, MD, Dermatology, PLLC | Ann Arbor | Michigan | 48103 | United States |
| Foot Healthcare Associates | Livonia | Michigan | 48152 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| Foot & Ankle Physicians | Union | New Jersey | 07083 | United States |
| St. John's Queens Hospital | Elmhurst | New York | 11373 | United States |
| North Shore Podiatry Group | Port Jefferson Station | New York | 11776 | United States |
| Calvary Hospital | The Bronx | New York | 10461 | United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
| UNC Wound Care Clinic | Durham | North Carolina | 27713 | United States |
| Eastern Carolina Foot & Ankle Specialists | Greenville | North Carolina | 27834 | United States |
| Bone, Spine, Sports Center | Bismarck | North Dakota | 58501 | United States |
| Austintown Podiatry Associates, Inc. | Austintown | Ohio | 44515 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Optimed Research, LLC | Columbus | Ohio | 43235 | United States |
| Lehigh Valley Podiatry Associates | Allentown | Pennsylvania | 18104 | United States |
| Advanced Regional Center for Ankle and Foot Care | Altoona | Pennsylvania | 16602 | United States |
| UPMC Horizon | Farrell | Pennsylvania | 16121 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Foot and Ankle Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Prigoff-Bowers, LLP | Dallas | Texas | 75224 | United States |
| Limb Salvage Center | Dallas | Texas | 75231 | United States |
| South Texas Foot Institute | Floresville | Texas | 78114 | United States |
| Memorial Hermann Wound Center | Houston | Texas | 77030 | United States |
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
| Barrett Quality Medical Interests, LP | San Antonio | Texas | 78216 | United States |
| San Antonio Podiatry Associates, PC | San Antonio | Texas | 78229 | United States |
| Richard G. Seegmiller, DPM | Bountiful | Utah | 84010 | United States |
| Douglas C. Flegal, DMP, FACFAS | Salt Lake City | Utah | 48103 | United States |
| Atlantic Foot & Ankle Center | Virginia Beach | Virginia | 23454 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-1100 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D048909 | Diabetes Complications |
| C000721267 | digital ulcers |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| C476036 | 2-(2-(4-chlorophenyl)ethoxy)adenosine |
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