None listed
Conditions
Brief summary
The HELP treatment implants two Peripheral Access Devices (PAD) in to a patients thigh. The devices are connected to a pump (outside of the body). Blood is taken from the upper device and pumped at higher pressure back in to the lower device. The higher pressure increases perfusion in to the diseased limb, reducing pain and promotes growth of new vessels.
Interventions
The Hypertensive Extracorporeal Limb Perfusion (HELP) procedure involves the temporary surgical implantation of two large bore access ports (Peripheral Access Devices - PAD) in to the femoral artery (thigh). The devices will be implanted (2hour procedure duration) for a maximum duration of 28 days after which the devices are removed.
Pressure and Flow are then generated by an extracorporeal pump taking the patients blood from one device and returning it in to the the treatment limb. This increa
The Hypertensive Extracorporeal Limb Perfusion (HELP) procedure involves the temporary surgical implantation of two large bore access ports (Peripheral Access Devices - PAD) in to the femoral artery (thigh). The devices will be implanted (2hour procedure duration) for a maximum duration of 28 days after which the devices are removed. Pressure and Flow are then generated by an extracorporeal pump taking the patients blood from one device and returning it in to the the treatment limb. This increased flow allows an improvement in perfusion to the diseased/occluded limb. Pumping sessions will last for around 24 hours at a time and may be repeated every other day for the total treatment period (28 days)
Sponsors
Advanced Surgical Design and Manufacture
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed