Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01658618
Status:
UNKNOWN
Last Update Posted:
2014-02-03
First Post:
2012-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
Sponsor:
Healthpoint
Organization:
Study Overview
Official Title:
A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
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.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: