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| ID | Type | Description | Link |
|---|---|---|---|
| D11AC00020 | Other Grant/Funding Number | DoD |
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| Name | Class |
|---|---|
| Arkios BioDevelopment International | INDUSTRY |
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This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plurogel PN | Experimental | Plurogel PN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plurogel PN | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ledesma Foot and Ankle | Phoenix | Arizona | 85032 | United States | ||
| Foot & Ankle Clinic |
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| Los Angeles |
| California |
| 90010 |
| United States |
| Samuel Merritt University | Oakland | California | 94609 | United States |
| ASAP Urgent-Care | Hamden | Connecticut | 06514 | United States |
| Advance Medical Research Center | Miami | Florida | 33135 | United States |
| Miami Center for Clinical Research, LLC | Miami | Florida | 33144 | United States |
| Unlimited Medical Research, LLC | Miami | Florida | 33144 | United States |
| Phoenix Medical Research, LLC | Miami | Florida | 33165 | United States |
| Med Research of Florida, LCC | Miami | Florida | 33186 | United States |
| Sweet Hope Research Specialty, Inc. | Miami Lakes | Florida | 33016 | United States |
| Weil Foot & Ankle Institute | Des Plaines | Illinois | 60016 | United States |
| Research Integrity | Owensboro | Kentucky | 42303 | United States |
| Paddington Testing Company, Inc | Philadelphia | Pennsylvania | 19103 | United States |
| AllCare Foot & Ankle, PA | Arlington | Texas | 76015 | United States |
| Coastal Podiatry Group | Virginia Beach | Virginia | 23464 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D007239 | Infections |
| D014947 | Wounds and Injuries |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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