Status:
COMPLETED
Safety Follow-Up to HP 802-247-09-015
Lead Sponsor:
Healthpoint
Conditions:
Venous Leg Ulcer
Venous Stasis Ulcer
Eligibility:
All Genders
18+ years
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 adve...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Provide informed consent
- Willing to comply with protocol instructions, including allowing all study assessments.
- Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
- Subject has ended their participation in HP 802-247-09-015 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00900029
Start Date
June 1 2009
End Date
January 1 2012
Last Update
August 2 2017
Active Locations (30)
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1
University of AZ College of Medicine
Tucson, Arizona, United States, 85724
2
Center for Clinical Research
Castro Valley, California, United States, 94546
3
ILD Consulting, Inc.
Encinitas, California, United States, 92024
4
Vascular Surgery Associates
Los Angeles, California, United States, 90048