Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06399900

ENhancing Exercise With LIGHT to Improve Functioning in PAD

Led by Northwestern University · Updated on 2026-04-15

32

Participants Needed

1

Research Sites

128 weeks

Total Duration

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AI-Summary

What this Trial Is About

The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up, compared to sham light, in people with lower extremity peripheral artery disease (PAD).

CONDITIONS

Official Title

ENhancing Exercise With 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
  • Diagnosis of peripheral artery disease (PAD) defined by one of the following:
    1. An ankle-brachial index (ABI) less than or equal to 0.90 at baseline
    2. Vascular lab evidence of PAD such as toe brachial pressure less than or equal to 0.70 or angiographic evidence showing at least 70% narrowing of an artery supplying the lower legs
    3. An ABI between greater than 0.90 and less than or equal to 1.00 with a 20% or greater drop in ABI in either leg after the 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 symptoms other than PAD
  • Current foot ulcer on the bottom of the foot
  • Failure to complete the study run-in phase
  • Planned major surgery or revascularization of coronary or leg arteries within the next four months
  • Major surgery, coronary or leg revascularization, or major cardiovascular event within the previous three months
  • Major medical illnesses including lung disease requiring oxygen, Parkinson's disease, life-threatening illness with less than six months life expectancy, or cancer requiring treatment in the past two years (some exceptions apply)
  • Mini-Mental Status Exam score below 23
  • Non-English speaking
  • Participation in or completion of another clinical trial in the previous three months (with timing exceptions for certain therapies)
  • Visual impairment that limits walking ability
  • Six-minute walk distance less than 400 feet or greater than 1700 feet
  • Participation in or planning to start a supervised treadmill exercise or cardiac rehabilitation program within specified recent or upcoming timeframes
  • Unwillingness to avoid red light therapy outside the study
  • Baseline blood pressure below 100/45
  • Investigator discretion based on safety or fit for the trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

M

Mary McDermott, MD

CONTACT

K

Kathryn Domanchuk

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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