Red Light Therapy for Peripheral Artery Disease

Overseen By Nicole L Lohr, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Pulmonary hypertension, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

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}

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.

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.

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.

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

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+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

Laser energy can effectively recanalize totally blocked peripheral arteries, improving blood flow in patients with peripheral vascular disease, which is less invasive than traditional surgery.

While laser-assisted balloon angioplasty shows promise for treating certain types of arterial blockages, its effectiveness is currently limited for long occlusions or below-the-knee disease compared to standard surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of laser angioplasty. Seeger, J., Abela, GS.[2007]

Irradiating the hind limb of mice with red light (670 nm) for 5-10 minutes significantly increased blood flow by promoting the release of a nitric oxide precursor, demonstrating its potential for enhancing vasodilation in ischemic tissues.

In a model simulating human peripheral artery disease, repeated light treatment over 14 days led to a sustained increase in blood flow in the affected limb, suggesting that this therapy could be a simple and effective home-based treatment for individuals with impaired blood circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Characterization of a Red Light-Activated Vasodilation: A Photobiomodulation Study. Keszler, A., Lindemer, B., Broeckel, G., et al.[2023]

In a study involving 22 patients with angina pectoris, intravascular red light therapy (IRLT) using a diode laser was found to be safe and successfully performed without any procedural complications.

At 6 months follow-up, the mean minimal lumen diameter was 2.57 mm, and only 4 patients developed angiographic restenosis, indicating that IRLT may effectively reduce the risk of restenosis after coronary stenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular Red Light Therapy after Coronary Stenting Ñ Angiographic and Clinical Follow-up Study in Humans. Kaul, U., Singh, B., Sudan, D., et al.[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]

Vascular photodynamic therapy (PDT) significantly increases the bursting pressure of rat iliac arteries shortly after treatment, indicating improved arterial wall strength compared to control groups.

However, after one year, while the bursting pressure remained stable in the lower energy PDT group, the higher energy group (100 J/cm) showed signs of aneurysmal dilatation, suggesting potential long-term risks associated with higher energy PDT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial wall strength after endovascular photodynamic therapy. Gabeler, EE., van Hillegersberg, R., Sluiter, W., et al.[2013]

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]

Direct laser light combined with percutaneous transluminal angioplasty (PTA) successfully recanalized atherosclerotic peripheral arteries in 92% of cases (33 out of 36 procedures), indicating high efficacy for this treatment method.

While there were some complications, including emboli and hematomas, the preliminary results suggest that direct laser angioplasty could be a valuable addition to standard PTA for treating blocked arteries, with a mean follow-up of 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct argon laser exposure for recanalization of peripheral arteries: early results. Nordstrom, LA., Castaneda-Zuniga, WR., Young, EG., et al.[2007]

In a study involving 27 patients with chronic femoropopliteal occlusions, the Nd-YAG laser system achieved initial clinical success in 69% of cases, significantly improving blood flow as indicated by the ankle-brachial pressure ratio.

However, the long-term results were disappointing, with a 1-year primary patency rate of only 12%, and a high incidence of complications such as vessel perforation (28%) and wall dissection (25%), suggesting that the current technique requires significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous laser recanalisation of femoropopliteal occlusions using continuous wave Nd-YAG laser and sapphire contact probe delivery system. Ashley, S., Brooks, SG., Gehani, AA., et al.[2019]

The xenon-hydrogen chloride excimer laser is highly effective for treating peripheral artery disease, achieving an 86% procedural success rate and a 93% limb salvage rate at 6 months in a study of 145 patients.

This laser operates using a nonthermal mechanism to ablate plaque, making it particularly beneficial for complex cases, although careful patient selection is necessary, especially for those with diabetes and renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]