Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia

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.

Timeline

Start

2006-05

Primary completion

2008-06

Completion

2008-06

Outcome

Outcome not reported

Stopped (Enrollment): “Very slow enrollment.Study entry criteria not in line w/local standards of care”

Drugs

Indications