Assessment of foot perfusion in patients with lower limb ischaemia
Research type
Research Study
Full title
The use of Hemodynamic Occlusive Vascular Response (HOVR™) technology to assess the impact of peripheral artery disease (PAD) on tissue perfusion and oxygenation in the foot.
IRAS ID
339260
Contact name
Patrick Coughlin
Contact email
Sponsor organisation
VOTIS Subdermal Imaging Technologies LTD
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
A large number of older people have poor circulation to their legs. This is known as peripheral arterial disease (PAD). When PAD is at its most severe, this can cause ulcers and gangrene which if not treated can lead to amputations of the leg. Diabetes is also a medical condition that is common. One of the consequences of diabetes is that is can increase the risk of PAD and can also damage the nerves in feet (known as sensory neuropathy) which means that affected people struggle to feel sensation in their feet. These two factors also predispose such patients to develop foot ulceration. The key to getting such ulcers healed is where required improving the blood flow down to the foot and also to treat any underlying infection. When assessing these patients it is vital that we can accurately assess the amount of blood flow that is getting in to the foot. Clinical examination (palpation of pulses in the ankle. / foot) can aid with this but it does not provide all the detail required. Specifically it does not provide an objective assessment (ie provide a specific number) of blood flow to the foot. An objective assessment is of benefit as it can provide a cut off value for when blood flow is deemed sufficient enough for foot ulcer and foot wounds to heel. Such an objective assessment is of benefit to determine whether to improve blood flow or not (to revascularise) and then to determine whether the revascularisation procedure has been sufficient to improve the blood flow enough to aid in ulcer healing. There are currently few technologies available to provide this information. We aim to test a new technology in patients to determine whether it is accurate, reliable and responsive to change in blood flow.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0133
Date of REC Opinion
29 Aug 2024
REC opinion
Further Information Favourable Opinion