Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
1 other identifier
observational
440
2 countries
49
Brief Summary
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:
- 1.to identify new adverse events,
- 2.to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
- 3.to record wound status, and
- 4.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Typical duration for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFebruary 3, 2014
January 1, 2014
2.5 years
August 1, 2012
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Exploratory Objectives
12 Months
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Subjects who refuse to provide written informed consent will be excluded from this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (49)
Unknown Facility
Glendale, Arizona, 85306, United States
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Tucson, Arizona, 85723, United States
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Carlsbad, California, 92009, United States
Unknown Facility
Castro Valley, California, 94546, United States
Unknown Facility
Laguna Hills, California, 92653, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Diego, California, 92013, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Stockton, California, 95204, United States
Unknown Facility
Sylmar, California, 91342, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Gainesville, Florida, 32605, United States
Unknown Facility
Hialeah, Florida, 33013, United States
Unknown Facility
Miami, Florida, 33125, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60616, United States
Unknown Facility
Jacksonville, Illinois, 62650, United States
Unknown Facility
North Chicago, Illinois, 60064, United States
Unknown Facility
Springfield, Illinois, 62702, United States
Unknown Facility
Baltimore, Maryland, 21224, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Cambridge, Massachusetts, 02138, United States
Unknown Facility
Las Vegas, Nevada, 89119, United States
Unknown Facility
Emerson, New Jersey, 07630, United States
Unknown Facility
New York, New York, 10025, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Akron, Ohio, 44307, United States
Unknown Facility
Tulsa, Oklahoma, 74127, United States
Unknown Facility
Dunmore, Pennsylvania, 18512, United States
Unknown Facility
Wyomissing, Pennsylvania, 19610, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Fort Worth, Texas, 76107, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
St. George, Utah, 84770, United States
Unknown Facility
Roanoke, Virginia, 24013, United States
Unknown Facility
Tacoma, Washington, 98431, United States
Unknown Facility
Vancouver, British Columbia, V5Z1M9, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E5J1, Canada
Unknown Facility
Hamilton, Ontario, L8R2R3, Canada
Unknown Facility
London, Ontario, N6C5J1, Canada
Unknown Facility
Sherbrooke, Quebec, J1H5N4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 7, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
February 3, 2014
Record last verified: 2014-01