Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06165016

Far Red Light to Improve Functioning in PAD

Led by Northwestern University · Updated on 2025-08-26

32

Participants Needed

2

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Far Red Light to Improve Functioning in PAD

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Diagnosed with Peripheral Artery Disease (PAD)
  • ABI (Ankle Brachial Index) less than or equal to 0.90 at baseline, or
  • Vascular lab evidence of PAD such as toe brachial pressure less than or equal to 0.70 or angiographic evidence of at least 70% artery narrowing in the lower legs, or
  • ABI greater than 0.90 and less than or equal to 1.00 with a 20% or greater drop in ABI after a heel-rise test
Not Eligible

You will not qualify if you...

  • Above- or below-knee amputation
  • Critical limb ischemia with ABI less than 0.40 and rest pain symptoms
  • Wheelchair confinement or requiring a walker to walk
  • Walking limited by causes other than PAD
  • Current foot ulcer on the bottom of the foot
  • Failure to complete the study run-in phase
  • Planned major surgery or leg/coronary revascularization in the next four months
  • Major surgery, revascularization, or major cardiovascular event in the past three months
  • Major illnesses such as lung disease requiring oxygen, Parkinson's disease, life-threatening illness with less than six months life expectancy, or cancer requiring treatment in past two years (except early stage cancer with excellent prognosis not in legs)
  • MMSE score less than 23
  • Non-English speaking
  • Participation in a clinical trial within the past three months with specific timing rules
  • Visual impairment limiting walking ability
  • Six-minute walk distance less than 400 feet or greater than 1700 feet
  • Participation in supervised treadmill exercise or cardiac rehabilitation in the past three months or plans to start in next five months
  • Unwillingness to avoid red light therapy outside the study
  • Baseline blood pressure less than 100/45
  • Investigator discretion for safety or suitability concerns

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

M

Mary McDermott, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Far Red Light to Improve Functioning in PAD | DecenTrialz