Using Near-Infrared Light to Better Understand Peripheral Artery Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Texas at Arlington

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Healthy Controls
Group B: Cases with PAD

Trial outcomes

Primary outcomes

1

Perceived Quality of life

Participants will complete a health questionnaire to gain a deeper understanding of their quality of life.

Time frame
Baseline and up to 26 weeks
2

Ankle- Brachial Index

The Ankle Brachial Index will be noninvasively assessed using the Smartdop XT device (Koven Technology, Inc.)

Time frame
Baseline and upto 26 weeks
3

Walking ability

Participants will complete a questionnaire to gain a deeper understanding of their walking ability

Time frame
Baseline and upto 26 weeks
4

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.

Time frame
Baseline and upto 26 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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