ACTRN12610000118000
Completed
N/A
In treating patients with Critical Limb Ischaemia (CLI) using Hypertensive Extracorporeal Limb Perfusion(HELP) when compared to conventional treatments the study evaluates Safety and Efficacy via a multicentre, controlled trial.
Advanced Surgical Design and Manufacture0 sites40 target enrollmentFebruary 4, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Advanced Surgical Design and Manufacture
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Only alternative treatment is imminent (within 8 weeks) major limb amputation
- •2\) At least two vascular surgeons must agree that the treatment is the only remaining option for the patients
- •3\) Patients must be over 18 years of age
- •4\) Patients have critical limb ischaemia
- •5\) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
- •6\) Patients must be fit for anaesthesia
- •7\) Patients must have suitable anatomy determined by pre\-operative imaging and physical examination
Exclusion Criteria
- •1\) Patients must not be in a concurrent clinical trial
- •2\) Patient must not have compartment syndrome
- •3\) Patients must not have an active systemic infection
- •4\) Patient must not have serum abnormalities or high Creatine Phosphokinase (CPK) (greater than 3x the upper limit of normal for the testing laboratory) as deemed by the clinical investigator
- •5\) Patients must not have general advanced debilitation or intercurrent organ failure
- •6\) Patients must not have a serious wound infection (for example, Methicillin\-resistant Staphylococcus aureus (MRSA) of the ulcer) that in the opinion of the Clinical Investigator may impede the response to treatment
- •7\) Patients must not have disseminated intravascular coagulation (DIC) as deemed by the clinical investigator
Outcomes
Primary Outcomes
Not specified
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