RecruitingNot Applicable

Red Light Treatment in Peripheral Artery Disease

United States40 participantsStarted 2018-01-17

Plain-language summary

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (\<.9 or \>1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants will be subjects between the ages of 18 and 85 who have been diagnosed with peripheral artery disease. Men and women will be recruited for participation. All ethnicities will be included in this study. Diagnosis of peripheral artery disease is defined as an Ankle Brachial index of \<0.9 or greater than 1.1 either at rest or during treadmill exercise. Exclusion Criteria: * Exclusionary criteria include age under 18 years and over 85 years, those who are unable to understand the consent process , those who cannot read or speak English, active pregnancy, hypersensitivity to perflutren contrast agents, pulmonary hypertension, active illicit drug use, untreated blood pressure over 160/95, sickle cell disease, or a history of intracardiac shunt. Additional exclusion criteria neurological diseases such as spinal stenosis, unspecified pain disorders, and any uncontrolled medical conditions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in blood flow

Timeframe: Baseline, 5 min of light, and up to 1 min after discontinuation of light

Trial details

NCT IDNCT03203239

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Nicole L Lohr, MD,PHD

414-996-3504 nlohr@uabmc.edu

View on ClinicalTrials.gov More Peripheral Artery Disease trials