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This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes:
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP802-247 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objectives | The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Chief Medical Officer | Study Chair |
| Tommy Lee, MSHS | Associate Director Clinical Operations | Study Director |
| Robert Kirsner, MD | Investigator | Principal Investigator |
| William Marston, MD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | 85306 | United States | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 13, 2016 | |
| Reset | Oct 31, 2016 | |
| Release | Jun 5, 2017 |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Phoenix | Arizona | 85012 | United States |
| Tucson | Arizona | 85723 | United States |
| Tucson | Arizona | 85724 | United States |
| Carlsbad | California | 92009 | United States |
| Castro Valley | California | 94546 | United States |
| Laguna Hills | California | 92653 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90095 | United States |
| San Diego | California | 92013 | United States |
| San Francisco | California | 94115 | United States |
| Stockton | California | 95204 | United States |
| Sylmar | California | 91342 | United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Gainesville | Florida | 32605 | United States |
| Hialeah | Florida | 33013 | United States |
| Miami | Florida | 33125 | United States |
| South Miami | Florida | 33143 | United States |
| Tamarac | Florida | 33321 | United States |
| Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60616 | United States |
| Jacksonville | Illinois | 62650 | United States |
| North Chicago | Illinois | 60064 | United States |
| Springfield | Illinois | 62702 | United States |
| Baltimore | Maryland | 21224 | United States |
| Boston | Massachusetts | 02118 | United States |
| Cambridge | Massachusetts | 02138 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Emerson | New Jersey | 07630 | United States |
| New York | New York | 10025 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Akron | Ohio | 44307 | United States |
| Tulsa | Oklahoma | 74127 | United States |
| Dunmore | Pennsylvania | 18512 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Dallas | Texas | 75390 | United States |
| Fort Worth | Texas | 76104 | United States |
| Fort Worth | Texas | 76107 | United States |
| San Antonio | Texas | 78229 | United States |
| St. George | Utah | 84770 | United States |
| Roanoke | Virginia | 24013 | United States |
| Tacoma | Washington | 98431 | United States |
| Vancouver | British Columbia | V5Z1M9 | Canada |
| Greater Sudbury | Ontario | P3E5J1 | Canada |
| Hamilton | Ontario | L8R2R3 | Canada |
| London | Ontario | N6C5J1 | Canada |
| Sherbrooke | Quebec | J1H5N4 | Canada |
| Reset | Jan 23, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 13, 2016 | Oct 31, 2016 | |||
| Jun 5, 2017 | Jan 23, 2018 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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