RecruitingNot Applicable

ENhancing Exercise With LIGHT to Improve Functioning in PAD

United States32 participantsStarted 2024-08-12

Plain-language summary

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).

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. An ABI \<= 0.90 at baseline.
✓. Vascular lab evidence of PAD (such as a toe brachial pressure \<= 0.70 or an ankle brachial index less than or equal to 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.

Exclusion criteria

✕. Above- or below-knee amputation
✕. Critical limb ischemia defined as an ABI \<0.40 with symptoms of rest pain
✕. Wheelchair confinement or requiring a walker to ambulate
✕. Walking is limited by a symptom other than PAD
✕. Current foot ulcer on bottom of foot
✕. Failure to successfully complete the study run-in
✕. Planned major surgery, coronary or leg revascularization during the next four months
✕. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months

What they're measuring

Six-Minute Walk Distance

Timeframe: Measured at baseline and 4-month follow-up

Six-Minute Walk Distance

Timeframe: Measured immediately after the first light treatment (within 15 minutes after the first treatment, acute effect)

Trial details

NCT IDNCT06399900

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Mary McDermott, MD

13125036419 mdm608@northwestern.edu

View on ClinicalTrials.gov More Peripheral Artery Disease trials