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Far red light therapy for Difficulty Walking (LIGHT PAD Trial)

Q: What is the safety profile of Far red light therapy for human subjects?

According to our team at Power, the safety of Far red light therapy was rated a 2 on a scale from one to three. This is due to Phase 2 trial status and lack of data regarding efficacy but there are some existing studies that have verified its security.

Q: Are there any available vacancies in this research project for participants?

Affirmative. The clinical trial is still recruiting, as indicated by the records on clinicialtrials.gov which were first posted on January 20th 2024 and last updated December 2nd 2023. 32 participants are needed at one medical site for this study.

Q: To what extent has the trial been populated with participants?

Yes, the research available on clinicaltrials.gov supports that this medical study is actively seeking participants. This trial was first posted to the platform on January 20th 2024 and underwent its most recent edit on December 2nd 2023. 32 individuals need to be recruited for this experiment from a single testing centre.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and four month follow-up

Awards & highlights

LIGHT PAD Trial 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.Check my eligibility

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.See study design

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.

LIGHT PAD Trial 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.

LIGHT PAD Trial 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

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

Secondary outcome measures

Gastrocnemius Perfusion

Six-Minute Walk Distance

Six-minute walk distance.

+1 more

Other outcome measures

Gastrocnemius Muscle Abundance of Myofibers with Central Nuclei

Gastrocnemius Muscle Abundance of Satellite Cells

Gastrocnemius Muscle COX Enzyme Activity

+6 more

LIGHT PAD 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,055 Total Patients Enrolled

Frequently Asked Questions

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

What is the safety profile of Far red light therapy for human subjects?

"According to our team at Power, the safety of Far red light therapy was rated a 2 on a scale from one to three. This is due to Phase 2 trial status and lack of data regarding efficacy but there are some existing studies that have verified its security."

Answered by AI

Are there any available vacancies in this research project for participants?

"Affirmative. The clinical trial is still recruiting, as indicated by the records on clinicialtrials.gov which were first posted on January 20th 2024 and last updated December 2nd 2023. 32 participants are needed at one medical site for this study."

Answered by AI

To what extent has the trial been populated with participants?

"Yes, the research available on clinicaltrials.gov supports that this medical study is actively seeking participants. This trial was first posted to the platform on January 20th 2024 and underwent its most recent edit on December 2nd 2023. 32 individuals need to be recruited for this experiment from a single testing centre."

Answered by AI