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Far Red Light Therapy for Peripheral Arterial Disease (LIGHT PAD Trial)

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be age 50 and older

Participants will have PAD defined as: An ABI < 0.90 at baseline, Vascular lab evidence of PAD, or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities, or 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

Must not have

Walking is limited by a symptom other than PAD

Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and four-month follow up

Summary

This trial tests if daily far red light on lower body can improve walking, blood flow, and muscle damage in people with PAD. Participants do 10 minutes of light treatment twice a day for 4 months.

Who is the study for?

This trial is for people over 50 with Peripheral Arterial Disease (PAD), evidenced by specific tests. They must be able to walk without a walker or wheelchair, not have critical limb ischemia, recent major surgeries, severe medical conditions like advanced lung disease or Parkinson's, and should not be in another clinical trial recently.

What is being tested?

The LIGHT PAD Trial is testing if far red light therapy can improve walking distance and blood flow in the legs of PAD patients compared to a fake light treatment. Participants will use the assigned light device on their lower extremities at home for ten minutes twice daily over four months.

What are the potential side effects?

Since this study involves light therapy as opposed to medication, side effects are expected to be minimal. However, potential risks may include skin irritation from the device or discomfort during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I have been diagnosed with PAD based on specific tests and criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My walking is limited by a condition that is not related to leg artery disease.

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I haven't had major surgery or significant heart issues in the last 3 months.

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I do not speak English.

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I can walk less than 400 feet or more than 1700 feet in six minutes.

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I have had an amputation above or below the knee.

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I have severe leg pain due to poor blood flow.

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I use a wheelchair or walker to move around.

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

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I do not have a severe illness like lung disease needing oxygen, Parkinson's, a life-threatening condition expected to last less than 6 months, or cancer treated in the last 2 years.

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My vision problems make it hard for me to walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured before and within five minutes after the final light treatment at four-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured before and within five minutes after the final light treatment at four-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured before and within five minutes after the final light treatment at four-month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Calf muscle perfusion

Six-Minute Walk Distance

Six-minute walk distance.

+1 more

Other study objectives

Gastrocnemius Muscle Abundance of Myofibers with Central Nuclei

Gastrocnemius Muscle Abundance of Satellite Cells

Gastrocnemius Muscle COX Enzyme Activity

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Far red light therapyExperimental Treatment1 Intervention

Subgroup of participants receiving the 670 nm far red light device

Group II: Sham therapyPlacebo Group1 Intervention

Subgroup of participants receiving 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.

0 / 12Eligibility criteria met