What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise programs, pharmacologic therapies, and various forms of light therapy. Supervised exercise programs, particularly high-intensity walking, can lead to muscle soreness and fatigue but are generally well-tolerated. Pharmacologic treatments, such as antiplatelet agents, may cause gastrointestinal discomfort, bleeding, or bruising. Light therapies, like the 670 nm Light Therapy, aim to enhance blood flow and nitric oxide production. While specific side effects for 670 nm Light Therapy are not detailed, light therapies in general can sometimes cause mild skin irritation or temporary changes in skin pigmentation. Overall, these treatments are considered safe with low rates of adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD) that focus on improving blood flow and reducing symptoms. These include antiplatelet agents like aspirin and clopidogrel, which help prevent blood clots, and medications such as cilostazol and pentoxifylline that improve blood flow and reduce claudication symptoms. While specific FDA approvals for light therapy, such as the 670 nm light therapy being studied, are not detailed, therapies that enhance nitric oxide production and vasodilation, like phosphodiesterase inhibitors, are relevant. Further research and clinical trials are necessary to establish the efficacy and safety of light-based therapies for PAD.

What other types of research exist?

Promising novel alternatives to 670 nm light therapy for PAD patients include: 1) Photodynamic therapy (PDT) with aminolevulinic acid, which has shown efficacy in enhancing blood flow and improving vascular health. 2) Violet LED light therapy (405 nm), which induces vasodilation through a soluble guanylate cyclase-dependent mechanism and increases superoxide dismutase (SOD) activity. 3) Lower extremity resistance training, which improves maximal strength and vascular function without adverse effects. These alternatives offer potential benefits in enhancing blood flow and nitric oxide production for PAD patients.

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Light Therapy

Red Light Therapy for Peripheral Artery Disease

N/A

Recruiting

Led By Nicole L Lohr, MD,PHD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of peripheral artery disease is defined as an Ankle Brachial index of <0.9 or >1.1 at rest or during treadmill exercise

Participants must be between the ages of 18 and 85 and diagnosed with peripheral artery disease

Must not have

Age under 18 years or over 85 years

Pulmonary hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 min after discontinuation of light

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the site of red light exposure such as skin irritation or discomfort. There might also be risks associated with the ultrasound contrast agent used during imaging, including allergic reactions or side effects related to nitric oxide metabolite measurement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with peripheral artery disease.

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I am between 18 and 85 years old and have been diagnosed with peripheral artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 85.

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I have high blood pressure in the lungs.

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I have sickle cell disease.

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I do not have any uncontrolled medical conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 5 min of light, and up to 1 min after discontinuation of light

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 5 min of light, and up to 1 min after discontinuation of light

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 min of light, and up to 1 min after discontinuation of light for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in blood flow

Secondary study objectives

Changes in nitric oxide metabolites

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise therapy, pharmacologic therapy, and revascularization procedures. Supervised exercise therapy improves walking ability and functional status by inducing vasodilation and enhancing blood flow. Pharmacologic treatments, such as statins and antiplatelet agents, reduce cardiovascular risk factors and improve blood flow. Revascularization procedures, including angioplasty and bypass surgery, restore blood flow to affected limbs. Treatments like 670 nm Light Therapy aim to enhance blood flow and nitric oxide production, which is crucial for vasodilation and improving oxygen delivery to tissues. These mechanisms are vital for PAD patients as they help alleviate symptoms, improve mobility, and reduce the risk of severe complications like limb amputation.

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