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Far red light therapy + home-based walking exercise for Peripheral Vascular Disease (ENLIGHTEN PAD Trial)

Q: How many individuals are currently enrolled as participants in this clinical study?

<p>Indeed, information on clinicaltrials.gov highlights the current recruitment status of this particular trial. It was initially made available on June 1st, 2024 and underwent its most recent update on April 30th, 2024. The trial is actively enrolling a total of 32 participants across one medical site.</p>

Q: Are there still available openings for new participants in this research study?

<p>Indeed, information available on clinicaltrials.gov indicates that this particular medical study is in the active recruitment phase. The trial was initially posted on June 1st, 2024, and recently updated on April 30th of the same year. A total of 32 participants are being sought from a single designated location.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ENLIGHTEN PAD Trial 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.Check my eligibility

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.See study design

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.

ENLIGHTEN PAD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 50 years old or older.

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I have been diagnosed with PAD based on specific tests.

ENLIGHTEN PAD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Gastrocnemius Perfusion

Mean Exercise Intensity

Mean Exercise Intensity During Six-Minute Walk

+4 more

Other outcome measures

Gastrocnemius Muscle Abundance of Myofibers with Central Nuclei

Gastrocnemius Muscle Abundance of Satellite Cells

Gastrocnemius Muscle Capillary Density

+9 more

ENLIGHTEN PAD 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,601 Previous Clinical Trials

915,632 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled as participants in this clinical study?

"Indeed, information on clinicaltrials.gov highlights the current recruitment status of this particular trial. It was initially made available on June 1st, 2024 and underwent its most recent update on April 30th, 2024. The trial is actively enrolling a total of 32 participants across one medical site."

Answered by AI

Are there still available openings for new participants in this research study?

"Indeed, information available on clinicaltrials.gov indicates that this particular medical study is in the active recruitment phase. The trial was initially posted on June 1st, 2024, and recently updated on April 30th of the same year. A total of 32 participants are being sought from a single designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ENhancing Exercise With LIGHT to Improve Functioning in PAD

Mary McDermott 2024. "ENhancing Exercise With LIGHT to Improve Functioning in PAD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06399900.

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