Bedside ultrasound scan for screening of arterial disease in diabetes
Research type
Research Study
Full title
The effectiveness of a focused point-of-care duplex ultrasound scan as a bedside screening tool to detect peripheral arterial disease in diabetes.
IRAS ID
226100
Contact name
Usman Jaffer
Contact email
Sponsor organisation
Imperial College NHS Healthcare Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Patients suffering from diabetes can develop foot ulceration. This is a frequent and challenging complication. It is the most common cause of amputations and costs the NHS approximately £1 billion per year.
Poor circulation to the legs is the most important risk factor for ulceration and also increases the chance of amputation and death. The presence of poor circulation must be detected early when an ulcer has occurred so that the circulation can be improved by having surgery.
However, this diagnosis is very difficult in diabetes. Patients often have numbness in their legs and so do not complain of typical symptoms. The walls of their blood vessels are also very hard, which makes examination difficult. Currently available tests can be helpful but are not very accurate. So many cases of poor circulation are misdiagnosed. There is a need for a better test to improve diabetic foot outcomes. A focused bedside ultrasound scan of the blood vessels at the ankle may be a more accurate test. This involves having a sensor and some jelly placed on the skin. It is safe, does not involve radiation and takes less than 5-minutes to complete. In this study we wish to evaluate whether this is an accurate test to detect poor circulation.
We plan to train members of the diabetic foot care teams at Imperial College NHS Healthcare Trust and Chelsea and Westminster Hospital NHS Foundation Trust to perform this test over a period of 8-weeks. These trained team member’s will then scan diabetic patients in their clinics over a period of 10-months to determine whether they have poor circulation or not. Scanned patients will then have an ultrasound scan of their whole leg by a vascular scientist. We will then compare the accuracy of the bedside scan with the departmental scan.
Summary of Results
The problem:
Poor circulation (also called peripheral arterial disease; PAD) is a major risk factor for diabetic foot ulceration and amputation. The detection (or diagnosis) of poor circulation in people with diabetes is difficult. A number of tests exist to detect poor circulation. However, there is confusion as to which is the best test.The study:
In this study we compared the diagnostic accuracy of commonly used bedside tests to determine which is the best.Overall, 305 people with diabetes who presented to 2 hospital diabetic foot clinics participated in this study. They were tested for poor circulation with the following tests.
1- The ability to feel foot pulses on clinical examination
2- Blood pressure at the ankle (called ankle-brachial pressure index or ABPI)
3- Blood pressure at the ankle (called ankle-brachial pressure index or ABPI)
4- Visible blood flow waveform (called Doppler)- this involves gently applying a small device and gel on the skin at the ankle.
5- Visible blood flow waveform (called PAD-scan)- this involves gently applying a small device and gel on the skin at the ankle.
6- Audible blood flow waveforms (called Doppler)- this also involves gently applying a small device and gel on the skin at the ankle.
7- Measurement of foot oxygen levels (called transcutaneous pressure of oxygen or TcPO2)
The results of these tests were then compared to the result of a more detailed ultrasound scan of the arteries in the leg (also called Duplex ultrasound or DUS).
Summary of findings:
A high proportion of participants had evidence of poor circulation (66.2%). Overall, PAD-scan demonstrated the highest accuracy as compared to other tests.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1447
Date of REC Opinion
21 Sep 2017
REC opinion
Favourable Opinion