Red Light Therapy for Peripheral Artery Disease

Recruiting in Palo Alto (17 mi)

Overseen by Nicole L Lohr, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Pulmonary hypertension, Sickle cell, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 4 10 11 12}

Research Team

Nicole L Lohr, MD,PHD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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.

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

Exclusion Criteria

I have a neurological condition like spinal stenosis or a pain disorder.

I am younger than 18 or older than 85.

Inability to understand the consent process or inability to read or speak English

Trial Timeline

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

Treatment Details

Interventions

• Red Light Treatment (Light Therapy)

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.

Participant Groups

Group I: Red Light treatment Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Dr. Joseph E. Kerschner

Medical College of Wisconsin

Chief Medical Officer since 2011

MD, specific institution not identified

Dr. John R. Raymond, Sr.

Medical College of Wisconsin

Chief Executive Officer since 2010

MD from the Medical University of South Carolina

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular applications of lasers. Faught, WE., Lawrence, PF.[2019]

Both low-level laser therapy and LED light sources can effectively induce vasodilation in porcine coronary arteries, with maximum relaxation observed at an energy density of 10 J/cm², achieving comparable results between the two light sources.

The vasodilation effect is mediated by a nitric oxide-dependent mechanism, suggesting that these light therapies could be beneficial in clinical settings, such as during coronary artery bypass surgery, to facilitate easier suturing of blood vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light-induced vasodilation of coronary arteries and its possible clinical implication. Plass, CA., Loew, HG., Podesser, BK., et al.[2015]

In a study involving 13 juvenile pigs, photodynamic therapy (PDT) using red light significantly improved the lumen size and reduced neointimal hyperplasia in balloon-injured coronary arteries compared to control, suggesting its efficacy in preventing artery narrowing after injury.

The results indicate that PDT not only minimizes neointimal growth but also maintains the lumen size of treated arteries similar to healthy segments, highlighting its potential as a safe and effective treatment for restenosis following endovascular procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in the response to coronary and iliac artery injury with photodynamic therapy using 5-aminolaevulinic acid. Jenkins, MP., Buonaccorsi, GA., Mansfield, R., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of lasers in the management of peripheral vascular disease. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Vascular applications of laser. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Vascular applications of lasers. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Current status of laser angioplasty. [2007]

5. Switzerland pubmed.ncbi.nlm.nih.gov

In Vivo Characterization of a Red Light-Activated Vasodilation: A Photobiomodulation Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Intravascular Red Light Therapy after Coronary Stenting Ñ Angiographic and Clinical Follow-up Study in Humans. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Light-induced vasodilation of coronary arteries and its possible clinical implication. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Arterial wall strength after endovascular photodynamic therapy. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Reduction in the response to coronary and iliac artery injury with photodynamic therapy using 5-aminolaevulinic acid. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Direct argon laser exposure for recanalization of peripheral arteries: early results. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Percutaneous laser recanalisation of femoropopliteal occlusions using continuous wave Nd-YAG laser and sapphire contact probe delivery system. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Excimer laser-assisted angioplasty for infrainguinal artery disease. [2022]