Using far red light to improve walking in people with Peripheral Artery Disease

Far Red Light to Improve Functioning in PAD: The LIGHT PAD Trial

This study is testing if daily far red light therapy can help people over 50 with Peripheral Artery Disease walk further and improve their leg health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT06165016 on ClinicalTrials.gov

What this trial studies

The LIGHT PAD Trial is a multi-centered randomized clinical trial designed to evaluate the effects of daily far red light treatment on individuals with Peripheral Artery Disease (PAD). Participants aged 50 and older will receive either far red light therapy or a sham treatment for 10 minutes twice daily over four months. The primary outcome is the change in six-minute walk distance, assessed at the end of the treatment period, along with secondary measures of lower extremity perfusion and muscle health. This trial aims to gather preliminary data that could inform future definitive studies on light therapy for PAD.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older diagnosed with Peripheral Artery Disease.

Not a fit: Patients with critical limb ischemia, amputations, or other conditions severely limiting mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance walking ability and overall quality of life for patients with PAD.

How similar studies have performed: While the use of light therapy is a novel approach in this context, similar studies have shown promising results in other conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria.

First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as:

1. An ABI \<= 0.90 at baseline.
2. Vascular lab evidence of PAD (such as a toe brachial pressure =\< 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
3. An ABI of \>0.90 and \<= 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.

Exclusion Criteria:

1. Above- or below-knee amputation
2. Critical limb ischemia defined as an ABI \<0.40 with symptoms of rest pain
3. Wheelchair confinement or requiring a walker to ambulate
4. Walking is limited by a symptom other than PAD
5. Current foot ulcer on bottom of foot
6. Failure to successfully complete the study run-in
7. Planned major surgery, coronary or leg revascularization during the next four months
8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent, unless the cancer is located in the lower extremities. Participants who require oxygen only at night may still qualify.\]
10. Mini-Mental Status Examination (MMSE) score \< 23
11. Non-English speaking
12. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
13. Visual impairment that limits walking ability.
14. Six-minute walk distance of \<400 feet or \>1700 feet.
15. Participation in a supervised treadmill exercise program or a cardiac rehabilitation program in previous three months or planning to begin a supervised treadmill exercise program or a cardiac rehabilitation program in the next five months.
16. Unwilling to avoid red light therapy outside of study participation.
17. Baseline blood pressure \<100/45.
18. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

Where this trial is running

Birmingham, Alabama and 1 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Mary McDermott, MD

Conditions Peripheral Artery Disease; Peripheral Vascular Disease; Aging; Walking, Difficulty; light therapy