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The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remodulin® (treprostinil sodium) Injection | Drug |
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wade, PhD | United Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida College of Medicine | Tampa | Florida | 33606 | United States | ||
| University of Massachusetts Memorial Health |
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| Worcester |
| Massachusetts |
| 01655 |
| United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407-1139 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Presbyterian Medical Center, Philadelphia Heart Institute | Philadelphia | Pennsylvania | 19104 | United States |
| South Carolina Heart Center | Columbia | South Carolina | 29204 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D016491 | Peripheral Vascular Diseases |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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