What this study is
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.
What's being tested
- Red Light (670 nm energy)
Intervention · DEVICE
Light Emitting Diode light source (670 nm wavelength with output up to 75mW/cm2) will be placed over the gastrocnemius muscle. The light will be on for 5 minutes.
- Octafluoropropane
Intervention · DRUG
All subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.
Study details
- Official title
- Vasodilatory Effects of Light on Peripheral Artery Disease
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Peripheral Artery Disease · Claudication, Intermittent · Vasodilation
- Enrolling
- 40 people
- Starts
- 2018-01-17
- Est. completion
- 2028-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Nicole L Lohr, MD PhD · Contact205-996-3504nlohr@uabmc.edu
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID 29388
Principal investigator
Nicole L Lohr, MD,PHD
Medical College of Wisconsin
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.