Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
This study is enrolling participants by invitation only.
Sponsor:
Healthpoint
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01658618
First received: August 1, 2012
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
- to record wound status, and
- 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.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
| Condition | Intervention |
|---|---|
|
Venous Leg Ulcer |
Biological: HP802-247 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer |
Resource links provided by NLM:
Further study details as provided by Healthpoint:
Primary Outcome Measures:
- Primary Objective [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Exploratory Objectives [ Time Frame: 12 Months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 440 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Provide informed consent document
- Subject was randomized in 802-247-09-029 and received at least one application of a test article.
- Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.
Exclusion Criteria:
- Subjects who refuse to provide written informed consent will be excluded from this trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658618
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| United States, Arizona | |
| Glendale, Arizona, United States, 85306 | |
| Phoenix, Arizona, United States, 85012 | |
| Tucson, Arizona, United States, 85724 | |
| Tucson, Arizona, United States, 85723 | |
| United States, California | |
| Castro Valley, California, United States, 94546 | |
| Encinitas, California, United States, 92024 | |
| Long Beach, California, United States, 90822 | |
| San Francisco, California, United States, 94121 | |
| San Francisco, California, United States, 94115 | |
| Stockton, California, United States, 95204 | |
| Sylmar, California, United States, 91342 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32605 | |
| Hialeah, Florida, United States, 33013 | |
| Miami, Florida, United States, 33125 | |
| South Miami, Florida, United States, 33143 | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Chicago, Illinois, United States, 60611 | |
| Jacksonville, Illinois, United States, 62650 | |
| North Chicago, Illinois, United States, 60064 | |
| Springfield, Illinois, United States, 62702 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02118 | |
| Cambridge, Massachusetts, United States, 02138 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Emerson, New Jersey, United States, 07630 | |
| United States, New York | |
| New York, New York, United States, 10025 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44307 | |
| United States, Pennsylvania | |
| Dunmore, Pennsylvania, United States, 18512 | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, Texas | |
| Dallas, Texas, United States, 75390 | |
| Fort Worth, Texas, United States, 76104 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| St. George, Utah, United States, 84770 | |
| United States, Virginia | |
| Roanoke, Virginia, United States, 24013 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98431 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z1M9 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8R2R3 | |
| London, Ontario, Canada, N6C5J1 | |
| Sudbury, Ontario, Canada, P3E5J1 | |
| Canada, Quebec | |
| Sherbrooke, Quebec, Canada, J1H5N4 | |
Sponsors and Collaborators
Healthpoint
Investigators
| Study Chair: | Herbert B Slade, MD | Chief Medical Officer |
| Study Director: | Tommy Lee, MSHS | Associate Director Clinical Operations |
| Principal Investigator: | Robert Kirsner, MD | Investigator |
| Principal Investigator: | William Marston, MD | Investigator |
More Information
No publications provided
| Responsible Party: | Healthpoint |
| ClinicalTrials.gov Identifier: | NCT01658618 History of Changes |
| Other Study ID Numbers: | 802-247-09-030 |
| Study First Received: | August 1, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Healthpoint:
|
Venous leg ulcer ulcer venous stasis compression |
venous venous stasis ulcer vlu hp802-247-09-029 |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Varicose Ulcer Skin Ulcer Skin Diseases |
Pathologic Processes Varicose Veins Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013