Safety Follow-Up to HP 802-247-09-015
- Conditions
- Venous Leg UlcerVenous Stasis Ulcer
- Interventions
- Biological: No HP802 TreatmentOther: No HP802 Vehicle Treatment
- Registration Number
- NCT00900029
- Lead Sponsor
- Healthpoint
- Brief Summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
- Detailed Description
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No HP802 Treatment No HP802 Treatment Treatment received in Study 802-247-09-015 was HP802 No HP802 Vehicle Treatment No HP802 Vehicle Treatment Treatment received in Study 802-247-09-015 was HP802 Vehicle
- Primary Outcome Measures
Name Time Method The Number of Participants With Closed Target Ulcers at Each Visit Over the 24-week study period, at each of the bi-monthly visits At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Number of Subjects With Target Wound Closed for the First Time During the Study Period. Over the 24-week study period, at each of the bi-monthly visits At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
University of AZ College of Medicine
🇺🇸Tucson, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
New England Sinai Hospital
🇺🇸Stoughton, Massachusetts, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New Jersey, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Advanced Foot and Ankle Center
🇺🇸Las Vegas, Nevada, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Vascular Surgery Associates
🇺🇸Los Angeles, California, United States
UCSD Wound Treatment and Research Center
🇺🇸San Diego, California, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Rosalind Franklin University
🇺🇸North Chicago, Illinois, United States
Johns Hopkins Wound Center
🇺🇸Baltimore, Maryland, United States
Vincent Giacalone
🇺🇸Emerson, New Jersey, United States
Overglook Hospital Wound Healing Program
🇺🇸Summit, New Jersey, United States
Harrisburg Foot and Ankle Center
🇺🇸Harrisburg, Pennsylvania, United States
Center for Advanced Wound Care
🇺🇸Reading, Pennsylvania, United States
Wound Care Consultants
🇺🇸Dallas, Texas, United States
Arlington Research Center
🇺🇸Arlington, Texas, United States
Peripheral Vascular Associates
🇺🇸San Antonio, Texas, United States
Southwest Regional Wound Care Center
🇺🇸Lubbock, Texas, United States
Lake Washington Vascular, PLLC
🇺🇸Bellevue, Washington, United States
Dixie Regional Medical Center's Wound Clinic
🇺🇸Saint George, Utah, United States
Providence Sacred Heart Medical Center Wound Clinic
🇺🇸Spokane, Washington, United States
Aging Rehabilitation & Geriatric Care Research Center
🇨🇦London, Ontario, Canada
ILD Consulting, Inc.
🇺🇸Encinitas, California, United States
Passavant Area Hospital
🇺🇸Jacksonville, Illinois, United States
Center for Clinical Research
🇺🇸Castro Valley, California, United States
Doctors Research Network
🇺🇸South Miami, Florida, United States
Robert J. Snyder
🇺🇸Tamarac, Florida, United States