About this trial
The goal of this study is to better understand how blood flows and how oxygen is utilized in the lower limbs of people who suffer from peripheral artery disease. This study will also assess how these factors affect treatment outcomes.
Specific aims include:
Aim 1: Utilize BB-NIR-DCS to differentiate PAD patients experiencing primary oxygen delivery limitations from those suffering from mitochondrial dysfunction.
Aim 2: Test the efficacy of BB-NIR-DCS at predicting individual responses to vascular intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cases, Aim 1
18 or older
willing to participate under the conditions described in the informed consent form (ICF)
eligible to sign the ICF
Disqualifiers
Cases, Aim 1
Ankle-Brachial Index >0.9 or <0.4
isolated disease in aorta/iliac vessels
unstable angina or myocardial infarction in past 12 months
Trial population
Cases- 80 individuals with PAD. Controls- 40 healthy volunteers, of similar age, sex, and ethnicity as the PAD cases.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Perceived Quality of life
Participants will complete a health questionnaire to gain a deeper understanding of their quality of life.
Ankle- Brachial Index
The Ankle Brachial Index will be noninvasively assessed using the Smartdop XT device (Koven Technology, Inc.)
Walking ability
Participants will complete a questionnaire to gain a deeper understanding of their walking ability
Functional performance
Participants will be asked to walk as much as they can for six minutes (up and down a long hallway). Then, they will be asked to walk on a treadmill at 2 mph (3.2 km/h) at a grade of 10% for all as long as they can, or for a maximum of 10 minutes.
Sponsors and contacts
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