Far Red Light to Improve Functioning in PAD

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Peripheral Artery Disease, Peripheral Vascular Disease, Aging, Walking, Difficulty

In brief

The LIGHT PAD Trial is a Phase II multi-centered randomized clinical trial to collect preliminary data to test whether daily far red light treatment of the lower extremities in people with PAD improves six-minute walk distance, lower extremity perfusion, and ischemia-related damage in gastrocnemius muscle at four-month follow-up, compared to a sham control. Participants will complete 10 minutes of twice daily home treatment with either far red light or a sham light for four months.

Key facts

Study ID

NCT06165016

Run by

Northwestern University

People needed

32

Starts

2024-02-14

Expected to finish

2026-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Above- or below-knee amputation
• Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain
• Wheelchair confinement or requiring a walker to ambulate
• Walking is limited by a symptom other than PAD
• Current foot ulcer on bottom of foot
• Failure to successfully complete the study run-in
• Planned major surgery, coronary or leg revascularization during the next four months
• Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
• 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.]
• Mini-Mental Status Examination (MMSE) score < 23
• Non-English speaking
• 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.]
• Visual impairment that limits walking ability.
• Six-minute walk distance of <400 feet or >1700 feet.
• 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.
• Unwilling to avoid red light therapy outside of study participation.
• Baseline blood pressure <100/45.
• 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 it is running

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

Full record on ClinicalTrials.gov

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