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Virus Therapy

Light Therapy and Exercise for PAD (ENLIGHTEN 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 (such as a toe brachial pressure < 0.70 or an ankle brachial index <= 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities, 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

Current foot ulcer on bottom of foot

Critical limb ischemia defined as an ABI <0.30 or <0.40 with symptoms of rest pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 4-month follow-up, 24 hours after the final treatment

Summary

This trial will test if shining a red light on the legs before walking exercises can improve walking distance in people with PAD compared to a fake light treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the far red light therapy are not detailed, but it's generally considered low-risk. The exercise might cause muscle soreness or fatigue.

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.

Exclusion Criteria

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

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

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I have severe leg pain at rest due to poor blood flow.

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I use a wheelchair or walker to move around.

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I do not have a severe illness like lung disease needing daily oxygen, Parkinson's, or another life-threatening condition expected to shorten my life to under six months. I haven't been treated for another cancer in the last two years.

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My vision problems make it hard for me to walk.

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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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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 4-month follow-up, 24 hours after the final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 4-month follow-up, 24 hours after the final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 4-month follow-up, 24 hours after the final treatment for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Gastrocnemius Perfusion

Mean Exercise Intensity

Mean Exercise Intensity During Six-Minute Walk

+4 more

Other study objectives

Gastrocnemius Muscle Abundance of Myofibers with Central Nuclei

Gastrocnemius Muscle Abundance of Satellite Cells

Gastrocnemius Muscle Capillary Density

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Far red light therapy + home-based walking exerciseExperimental Treatment2 Interventions

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

Group II: Sham therapy + home-based walking exercisePlacebo Group2 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.

0 / 11Eligibility criteria met