Trials / Terminated
TerminatedNCT00300040
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Biopure Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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 (1:1) to receive either HBOC-201 or a colloid control (HAES-steril® 6%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hemoglobin glutamer 250 - bovine | intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL) |
| DRUG | 6% Hydroxyethylstarch | 250ml for intravenous infusion |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2006-03-08
- Last updated
- 2008-05-16
Locations
5 sites across 2 countries: South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT00300040. Inclusion in this directory is not an endorsement.