40 Participants Needed

Red Light Therapy for Peripheral Artery Disease

NL
Overseen ByNicole L Lohr, MD,PHD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves shining a special red light on the calf muscle of patients with poor leg blood flow due to peripheral artery disease. The goal is to see if this light can improve blood flow by helping the blood vessels work better, possibly through increasing nitric oxide levels.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is red light therapy safe for humans?

Research shows that red light therapy, including intravascular red light therapy, has been used safely in humans, with studies reporting no major complications during procedures and low rates of adverse events in follow-up.12345

How does Red Light Therapy differ from other treatments for Peripheral Artery Disease?

Red Light Therapy is unique because it uses non-invasive light at a specific wavelength (670 nm) to potentially improve blood flow, unlike traditional laser treatments that physically remove blockages in arteries. This approach may offer a gentler alternative with fewer risks of damaging the arterial walls.678910

What data supports the effectiveness of Red Light Therapy for Peripheral Artery Disease?

Research shows that 670 nm red light can increase blood flow by causing blood vessels to widen, which may help improve circulation in conditions like peripheral artery disease.5891112

Who Is on the Research Team?

NL

Nicole L Lohr, MD,PHD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with peripheral artery disease, indicated by an ankle brachial index outside the normal range. It's open to all ethnicities. Excluded are those under 18 or over 85, pregnant women, individuals sensitive to perflutren contrast agents, those with uncontrolled medical conditions like high blood pressure or sickle cell disease, and people who can't understand the consent process.

Inclusion Criteria

I have been diagnosed with peripheral artery disease.
I am eligible regardless of my gender or ethnicity.

Exclusion Criteria

I have a neurological condition like spinal stenosis or a pain disorder.
I have high blood pressure in the lungs.
Your blood pressure is higher than 160/95 and you are not receiving treatment for it.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a single 5-minute exposure to 670 nm light, with blood flow measured by ultrasound and blood samples collected for nitric oxide metabolites

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Red Light Treatment
Trial Overview The study tests a single five-minute exposure of red light therapy on the lower leg muscle in patients with peripheral artery disease. The aim is to see if this treatment improves blood flow as measured by ultrasound after injecting a special contrast agent. Blood samples will also be taken to check for changes in nitric oxide levels.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Red Light treatmentExperimental Treatment2 Interventions
This is a single arm design. All subjects will be enrolled to have peripheral blood flow measured before, during, and after red light exposure.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

Laser technology has shown promise in treating completely blocked blood vessels, particularly in peripheral vascular disease, but concerns remain about potential damage to the arterial walls, including perforation.
The presentation discusses the initial experiences with a new hybrid laser probe used in angioscopically guided laser-assisted angioplasty, indicating advancements in laser treatment methods for lower extremity vascular issues.
The role of lasers in the management of peripheral vascular disease.Sanfelippo, PM.[2017]
Recent advancements in laser technology have improved its potential for treating peripheral vascular disease through percutaneous revascularization, but its effectiveness is still under investigation.
Current use of lasers in vascular disease treatment is considered experimental, highlighting the need for more clinical studies to establish their safety and efficacy.
Vascular applications of laser.Cragg, AH., Gardiner, GA., Smith, TP.[2007]
Recent advancements in laser technology have significantly improved our ability to treat vascular diseases, leading to various clinical applications such as laser endarterectomy and laser angioplasty.
These laser techniques enhance the effectiveness of traditional procedures by targeting blood vessels more precisely, which may improve patient outcomes in cardiovascular disease management.
Vascular applications of lasers.Faught, WE., Lawrence, PF.[2019]

Citations

The role of lasers in the management of peripheral vascular disease. [2017]
Vascular applications of laser. [2007]
Vascular applications of lasers. [2019]
Current status of laser angioplasty. [2007]
In Vivo Characterization of a Red Light-Activated Vasodilation: A Photobiomodulation Study. [2023]
Intravascular Red Light Therapy after Coronary Stenting Ñ Angiographic and Clinical Follow-up Study in Humans. [2019]
Light-induced vasodilation of coronary arteries and its possible clinical implication. [2015]
Arterial wall strength after endovascular photodynamic therapy. [2013]
Reduction in the response to coronary and iliac artery injury with photodynamic therapy using 5-aminolaevulinic acid. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Direct argon laser exposure for recanalization of peripheral arteries: early results. [2007]
Percutaneous laser recanalisation of femoropopliteal occlusions using continuous wave Nd-YAG laser and sapphire contact probe delivery system. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Excimer laser-assisted angioplasty for infrainguinal artery disease. [2022]
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