Red light treatment for improving blood flow in peripheral artery disease
Vasodilatory Effects of Light on Peripheral Artery Disease
This study is testing if a short exposure to red light can improve blood flow in the legs of people with peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03203239 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a single 5-minute exposure to 670 nm red light on blood flow in the gastrocnemius muscle of patients diagnosed with peripheral artery disease. Participants will undergo blood flow measurement using contrast-enhanced ultrasound before and after the light exposure, along with blood samples collected to assess nitric oxide metabolites. The study aims to determine if this non-invasive treatment can enhance vasodilation and improve circulation in affected individuals. It is designed to be completed in one visit, with a possibility of a second visit if data quality requires it.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with peripheral artery disease, as indicated by an abnormal ankle-brachial index.
Not a fit: Patients under 18 or over 85, those with certain medical conditions, or those unable to understand the consent process may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, non-invasive method to improve blood flow and alleviate symptoms in patients with peripheral artery disease.
How similar studies have performed: While the use of red light therapy is gaining interest, this specific approach in peripheral artery disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Nicole L Lohr, MD,PHD — Medical College of Wisconsin
- Study coordinator: Nicole L Lohr, MD,PHD
- Email: nlohr@uabmc.edu
- Phone: 414-996-3504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.