Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300040
Status:
TERMINATED
Last Update Posted:
2008-05-16
First Post:
2006-03-06
Brief Title:
SafetyFeasibility Study of HBOC-201 in Amputation atBelow Knee From Critical Lower Limb Ischemia
Sponsor:
Biopure Corporation
Organization:
Biopure Corporation
Study Overview
Official Title:
Phase II Multi-CenterSingle-BlindPlacebo-Controlled StudyEvaluating Safety Feasibility of HBOC-201 Wound Healing Patients With Peripheral Vascular Disease Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very slow enrollmentStudy entry criteria not in line wlocal standards of care
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation
The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation
The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation
Detailed Description:
This is a Phase II single-blinded prospectively randomized parallel-group placebo controlled study that will evaluate the safety and feasibility of HBOC-201 when administered therapeutically to patients with a peripheral vascular occlusive disorder and who are undergoing lower limb amputation due to critical lower limb ischemia Subjects will be randomized 11 to receive either HBOC-201 or a colloid control HAES-steril 6
Study Oversight
Has Oversight DMC:
None
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?:
None