Light Therapy and Exercise for PAD

(ENLIGHTEN PAD Trial)

Overseen By Kathryn Domanchuk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Amputation, Critical limb ischemia, Wheelchair, 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: Unknown

Duration: 16 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 the treatment Light Therapy and Exercise for PAD?

Research shows that light therapy, including low-level laser and LED therapies, can help with healing and reducing inflammation in various conditions. It has been used effectively for pain management, wound healing, and improving blood flow, which may suggest potential benefits for conditions like PAD (peripheral artery disease). ^{1 2 3 4 5}

Is light therapy safe for humans?

Light therapy, also known as photobiomodulation, has been used safely in various treatments, including pain management and dental procedures. It is generally considered safe, with studies showing positive effects like pain reduction and healing stimulation without significant adverse effects. ^{1 2 5 6 7}

How does Far Red Light Therapy differ from other treatments for PAD?

Far Red Light Therapy is unique because it uses red and near-infrared light to stimulate healing, reduce pain, and decrease inflammation without the need for drugs or invasive procedures. This non-invasive approach enhances cellular energy production and promotes tissue repair, which is different from traditional treatments that may rely on medication or surgery. ^{1 2 6 8 9}

What is the purpose of this trial?

The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up, compared to sham light, in people with lower extremity peripheral artery disease (PAD).

Eligibility Criteria

This trial is for individuals with peripheral artery disease (PAD), which often causes difficulty walking and limited mobility due to poor blood flow in the legs. Participants should be able to perform home-based exercises and have no conditions that would interfere with light therapy.

Inclusion Criteria

I am 50 years old or older.

I have been diagnosed with PAD based on specific tests.

Exclusion Criteria

I have a current foot ulcer on the bottom of my foot.

I use a wheelchair or walker to move around.

Failure to successfully complete the study run-in

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions

16 weeks

Daily sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Far Red Light Therapy
• Home-based walking exercise

Trial Overview The ENLIGHTEN PAD Trial is testing if shining a special red light on the lower legs before walking exercises can improve walking distance after four months, compared to using a fake light treatment in people with PAD.

Participant Groups

Group I: Far red light therapy + home-based walking exercise Experimental Treatment 2 Interventions

Subgroup of participants receiving home-based walking exercise and the 670 nm far red light device

Group II: Sham therapy + home-based walking exercise Placebo Group 2 Interventions

Subgroup of participants receiving home-based walking exercise and the sham light device, far red light device covered with blue filter paper to block 670 nm light, resulting in mean power generated of 0.24 mW/cm2, compared to 26.3 mW/cm2 for the intervention, a 100-fold difference.

Far Red Light Therapy is already approved in United States for the following indications:

Approved in United States as Red Light Therapy for:

• Pain relief
• Muscle and joint aches
• Arthritis pain and stiffness
• Tendinitis pain

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Photobiomodulation, or light therapy using low-energy red lasers, shows promise for treating a variety of medical conditions, including neurological issues like stroke and traumatic brain injury, as well as pain management and skin conditions.

The mechanisms of action for photobiomodulation are still not fully understood, but research indicates that red lasers can penetrate the skull, suggesting potential therapeutic effects on brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective on Broad-Acting Clinical Physiological Effects of Photobiomodulation. Shanks, S., Leisman, G.[2019]

Low-level light therapy (photobiomodulation) shows promising benefits in periodontal and dental implant treatments, including enhanced healing and reduced inflammation, based on a review of various studies.

Despite the positive effects observed, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based treatment protocols for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Photobiomodulation therapy (PBMT) using red and near-infrared light is more effective for promoting keratinocyte activity compared to blue light, with optimal results typically occurring at energy densities between 0.1-5.0 J/cm2.

Higher energy densities above 15.0 J/cm2 were found to be ineffective or even harmful, leading to cell death, highlighting the importance of proper light dosimetry in PBMT applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation effects on keratinocytes cultured in vitro: a critical review. de Abreu, PTR., de Arruda, JAA., Mesquita, RA., et al.[2020]

Low level light therapy (LLLT) using specific wavelengths of LED light (633 nm and 830 nm) has been shown to effectively enhance wound healing and reduce pain and inflammation, supported by both animal and human studies.

LED-LLLT can significantly improve outcomes for non-healing wounds and accelerate healing in normal wounds, making it a promising adjunct treatment alongside traditional surgical and nonsurgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? Kim, WS., Calderhead, RG.[2022]

Photobiomodulation therapy, which includes low-level laser therapy and light-emitting diodes, has gained significant attention over the past decade for its potential to enhance athletic performance and accelerate post-exercise recovery, as supported by recent systematic reviews and randomized controlled trials.

The article emphasizes the importance of establishing clinical and scientific recommendations based on high-quality evidence to guide the proper use of photobiomodulation therapy, ensuring that future studies avoid relying on less rigorous data such as animal experiments or anecdotal case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: current evidence and future directions. Leal-Junior, ECP., Lopes-Martins, RÁB., Bjordal, JM.[2022]

Low-level light therapy (LLLT) has been shown to be a safe and effective treatment for skin rejuvenation, acne vulgaris, and body contouring, supported by a reasonable amount of clinical trial evidence.

Despite its commercial success, the quality of evidence for LLLT is limited by methodological flaws and small sample sizes, highlighting the need for more rigorous, independent clinical trials to validate its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Glass, GE.[2022]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low Level Laser Therapy (LLLT) has shown potential in improving wound healing and reducing pain, inflammation, and swelling, with mechanisms of action observed at both cellular and tissue levels.

LLLT may soon be applicable to serious conditions like stroke and traumatic brain injury, as the field expands to include various light sources and wavelengths, supported by randomized controlled clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nuts and bolts of low-level laser (light) therapy. Chung, H., Dai, T., Sharma, SK., et al.[2022]

Photobiomodulation therapy, or laser therapy, uses red and near-infrared light to promote healing, alleviate pain, and decrease inflammation in veterinary medicine.

While there is growing evidence supporting its effectiveness for certain conditions, the results are mixed or limited for others, indicating that more research is needed to fully understand its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation (Therapeutic Lasers): An Update and Review of Current Literature. Bunch, J.[2023]

References

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

Perspective on Broad-Acting Clinical Physiological Effects of Photobiomodulation. [2019]

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

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation effects on keratinocytes cultured in vitro: a critical review. [2020]

4. Japan pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: current evidence and future directions. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. [2022]

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

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]

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

The nuts and bolts of low-level laser (light) therapy. [2022]

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

Photobiomodulation (Therapeutic Lasers): An Update and Review of Current Literature. [2023]