Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

Completed · Not applicable

Conditions studied: Peripheral Artery Disease, Amputation, Smoking, Diabetes, Hypercholesterolemia, Hypertension

In brief

Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease. Older age (\> 65 years), smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known to have increased morbidity and mortality.Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative Services Task Force as an affordable and effective screening tool for evaluating PAD risk. QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device that is used as a screening tool to measure ABI of patients at risk of PAD. This single center prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD.

Key facts

Study ID

NCT03161327

Run by

St. Louis University

People needed

238

Starts

2017-07-15

Expected to finish

2017-09-14

Last updated by the study team

2018-12-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Answering yes to any of the following questions on the clinical screening questionnaire:
• Are you 65 years or older?
• Have you ever smoked?
• Do you have diabetes?
• Do you have high blood pressure or take medication for high blood pressure?
• Do you have high cholesterol, or take medication for high cholesterol?
• Have you previously had a stroke?
• Do you have heart disease?
• Do you experience any pain at rest in your lower legs or feet?
• Do you have discomfort (aching, fatigue, tingling, cramping or pain) when you walk, which is relieved by rest? Does the pain go away within 10 minutes after stopping?
• Are your toes or feet pale, discolored, or bluish?
• Do you have an infection, skin wound, or ulcer on your feet or toes?

You may not qualify if…

• Not meeting the above criteria.
• Previously screened with ABI in past 12 months

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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