A Multicentre, Controlled Trial to Determine the Safety and Efficacy of Hypertensive Extracorporeal Limb Perfusion(HELP) in Treating Patients with Critical Limb Ischaemia (CLI)

Not Applicable

Completed

• Conditions: Critical Limb Ischemia; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12610000118000
• Lead Sponsor: Advanced Surgical Design and Manufacture

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine safety and efficacy of Hypertensive Extracorporeal Limb Perfusion in preventing major limb amputation by examination for harm (Serious Adverse Events - including Minor Amputations ,Significant infection. haematoma or haemorrhage, Clinically significant thrombosis,Haemolysis) or further treatment (amputation)[6 months after explantation of the PAD devices]

Secondary Outcome Measures

Name	Time	Method
Relief of symptoms of peripheral vascular disease - determined by thermography, ultrasound, physical examination, questionnaires[6 months after explantation of the PAD devices];Healing of ulcers determined by photographic records and physical examinations[6 months after explantation of the PAD devices];Increased distal perfusion determined by ankle brachial index (ABI) and also by ultrasound exam[6 months after explantation of the PAD devices]