Actively Recruiting
ENhancing Exercise With LIGHT to Improve Functioning in PAD: the ENLIGHTEN PAD Trial
Led by Northwestern University · Updated on 2026-04-15
32
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to gather early data to determine if daily treatment with 660 nm far red light on the legs before home-based walking exercise improves walking distance over four months for people with lower extremity peripheral artery disease (PAD). The trial also examines immediate effects of the first light treatment on walking distance and intensity, and explores biological changes related to exercise benefits in PAD. This Phase II study is conducted at two centers with 32 participants. Participants will be randomly assigned to one of two groups: one group receives the 660 nm far red light treatment plus home-based walking exercise, while the other receives a sham light device plus the same walking exercise. Both groups use their assigned light devices on each leg twice daily for 10 minutes at home, guided by study staff who set up device positioning and timing. The walking exercise lasts 16 weeks with initial in-person coaching and then weekly phone follow-up. During the study, participants' walking ability will be measured by the six-minute walk test at baseline and after 4 months, including immediate effects after the first light treatment. Exercise intensity is tracked using a wrist-worn accelerometer. Researchers will also assess leg blood flow, muscle health, and related biomarkers from blood samples. Safety and adherence to treatments are monitored throughout, with participant involvement lasting the full 4-month intervention period.
CONDITIONS
Brief Title
ENhancing Exercise With LIGHT to Improve Functioning in PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 50 years and older
- Diagnosis of peripheral artery disease (PAD) confirmed by ankle brachial index (ABI) ≤ 0.90, vascular lab evidence (toe brachial pressure ≤ 0.70 or ABI ≤ 0.90), angiographic evidence of ≥70% artery stenosis, or ABI >0.90 and ≤1.00 with ≥20% drop after heel-rise test
- Ability to participate in home-based walking exercise
You will not qualify if you...
- Above- or below-knee amputation
- Critical limb ischemia with ABI <0.40 and rest pain
- Wheelchair confinement or requiring a walker to walk
- Walking limited by symptoms other than PAD
- Current foot ulcer on bottom of foot
- Failure to complete study run-in
- Planned major surgery or revascularization in next four months
- Major surgery, revascularization, or cardiovascular event in past three months
- Major medical illnesses including lung disease requiring oxygen, Parkinson's disease, life-threatening illness with less than six months expectancy, or cancer treatment in past two years (except early stage cancer with excellent prognosis not in lower extremities)
- Mini-Mental Status Examination score <23
- Non-English speaking
- Participation in clinical trial within last three months (with certain exceptions for stem cell or gene therapy)
- Visual impairment limiting walking ability
- Six-minute walk distance <400 feet or >1700 feet
- Participation in supervised treadmill or cardiac rehab in last three months or planning to start one soon
- Unwillingness to avoid red light therapy outside the study
- Baseline blood pressure <100/45
- Investigator discretion for safety or fit for trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive far red light therapy or sham light therapy devices to use daily at home, exposing their bare legs to the devices for 10 minutes twice per day.
Devices delivered to participants' homes by study coordinator
Duration - 16 weeks
Participants engage in a home-based walking exercise program guided by a study coach. This includes 4 in-person visits in the first four weeks and weekly phone calls for the remaining 12 weeks.
4 in-person visits and weekly phone calls for 12 weeks
Duration - At 4 months post-enrollment
Participants undergo assessments including six-minute walk distance and other measures at the 4-month follow-up after the intervention ends.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
M
Mary McDermott, MD
K
Kathryn Domanchuk
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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