Title: Automated measurement of ankle brachial pressure index for assessing the presence of peripheral arterial disease in people with leg ulceration [DAP63]
Funder: Department of Health and Social Care

Abstract: Leg ulcers are long-lasting sores that develop between the knee and the ankle and are slow to heal. They are common in adults, especially in older people. Most leg ulcers happen because of problems in the blood flow in the veins and usually are treated by applying bandages or stockings that squeeze the leg to create a ‘compression’ effect. However, this can harm the blood flow in the leg and should not be used in people with a condition called Peripheral Artery Disease, abbreviated as PAD. The main symptom is leg pain when walking. If untreated, PAD can cause serious problems including the risk of leg amputation. People with PAD are also at risk of developing heart problems and stroke. It is important to make sure that people with leg ulcers receive the right treatment and therefore it is recommended to check whether they suffer from PAD. To recognise the presence of PAD and identify people who should not receive compression therapy, the medical staff use a measurement called ‘Ankle Brachial Pressure Index’ or ‘ABPI’, which measures the pressure in the ankle. ABPI measurement is usually carried out by medical staff using a hand-held device (called Doppler ultrasound) and a manually inflated blood pressure cuff. The procedure is time-consuming and usually, people with leg ulcers find it uncomfortable. Automatic devices can be used instead of hand-held devices to speed up the procedure and make it more acceptable for people with leg ulcers. However, we need to know whether these devices produce reliable results and offer additional benefits compared to current methods (for example if they are easier or faster to perform and more comfortable for the person being tested)._x000D_ _x000D_ The purpose of this assessment is to bring together the data available and decide whether the use of automated devices for identifying PAD in people with leg ulcers is effective and represents good value for money as well as good use of NHS resources. We intend to compare the costs (e.g., cost of the device, cost of treatment) and benefits (e.g., patient survival and quality of life) of the existing automated devices to determine the best use of NHS resources and inform clinical practice and policy.

Lay abstract: The main objectives of this assessment are the following:_x000D_ _x000D_ • To determine the diagnostic performance and clinical utility of automated devices available in UK clinical practice (BlueDop doppler device [BlueDop Medical], boso ABI-system 100 [BOSCH + SOHN], WatchBP Office ABI [Microlife], WatchBP Office Vascular [Microlife]), MESI ABPI MD [MESI], MESI mTABLET ABI (MESI), Dopplex Ability Automatic ABI System [Huntleigh Healthcare]) for assessing the presence of PAD in people with leg ulcers._x000D_ _x000D_ • To develop an economic model to assess the cost-effectiveness of the automated devices available in UK clinical practice for assessing the presence of PAD in people with leg ulcers.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: BLOOD;SKIN