TerminatedPhase 2

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

Stopped: Very slow enrollment.Study entry criteria not in line w/local standards of care

South Africa, United Kingdom16 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects ≥ 18 ≤ 75 years of age * Scheduled amputation at or above ankle joint, or a more proximal location but below or through the knee joint * Documented severe lower extremity peripheral artery occlusive disease confirmed by clinical symptoms of critical limb ischemia and: * Frankly gangrenous tissue that merits amputation or * Angiographic evidence of occlusive peripheral artery disease within one month of screening * Participant or legal representative signs informed consent * Willingness to follow study instructions and follow-up visits Exclusion Criteria: * No informed consent is obtained * If medically inappropriate to administer 250 mL colloidal solution daily for 4 consecutive days * Uncontrolled hypertension (BP \> 160/90 mm Hg) despite 2 antihypertensive meds or BP \> 180/100 mm Hg if untreated * Severe liver dysfunction defined by Total Bilirubin \> 3 mg/dL or twice the normal limit of serum AST or ALT * Symptomatic CVD diagnosed w/ in last 6 months or known high grade carotid stenosis * Any severe or unstable medical condition that might interfere w/ the evaluation of study medication * Cardiogenic shock (cardiac index \< 2 L/min/m2, PCWP \> 18 mm Hg) * Amputation above knee joint or below ankle joint * Any amputation whereby primary skin closure not technically feasible * Candidate for percutaneous or surgical revascularization * Cardiac failure defined by a NY class III/IV or left ventricular ejection fraction \< 30% * Life expec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality at 60 days post amputation procedure

Timeframe: 60(±7 days) post-procedure follow-up visit

Trial details

NCT IDNCT00300040

SponsorBiopure Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06

View on ClinicalTrials.gov More Peripheral Vascular Disease trials