Red Light Treatment in Peripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Red Light (670 nm energy)
DeviceLight 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
DrugAll subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Red Light treatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in blood flow
Video intensity units from contrast images will be converted to ml/min/g tissue
Time frame
Baseline, 5 min of light, and up to 1 min after discontinuation of lightSecondary outcomes
1
Changes in nitric oxide metabolites
NO measurement by ozone chemiluminescence
Time frame
Baseline and 1 min after discontinuation of lightSponsors and contacts
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Source ClinicalTrials.gov