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.
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. Participants with PAD will be randomized at one of two centers: Northwestern University (PI: MM McDermott, MD) and the University of Alabama (PI: Nicole Lohr MD, PhD) to daily far red light or sham control for four months. The primary outcome, change in six-minute walk, will be measured at four month follow-up, immediately after the final administration of far red light or sham. In secondary and exploratory aims, investigators will distinguish between acute and chronic effects of far red light on six-minute walk, measure the effects of far red light on patient-reported outcomes, and delineate biologic pathways by which far red light improves walking performance in PAD, by measuring change in plasma nitrite and nitrosothiols, gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health and mitochondrial activity. If the proposed hypotheses are supported by this Phase II trial, results will be used to design a definitive randomized trial of far red light for people with PAD. To achieve the specific aims, investigators will randomize 32 participants age 50 and older with PAD to one of two groups: far red light therapy or sham therapy. Participants will be followed for four months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
All participants will receive one far red light device per leg. Participants will be asked to use their two light devices daily, exposing their bare legs to the devices for 10 minutes twice per day. A study coordinator will deliver the light devices to each participant's home, positioning the devices 15 cm behind the participant's heels, using tape on the floor to mark where the light and feet should be positioned. Twice each day, the participant flips a switch on the device to begin each session. A timer will turn off the device after 10 minutes. A power meter will measure the total time that the device was turned on. Participants will also record use of the light in a log.
All participants will receive one sham device per leg. Participants will be asked to use their two light devices daily, exposing their bare legs to the devices for 10 minutes twice per day. A study coordinator will deliver the light devices to each participant's home, positioning the devices 15 cm behind the participant's heels, using tape on the floor to mark where the light and feet should be positioned. Twice each day, the participant flips a switch on the device to begin each session. A timer will turn off the device after 10 minutes. A power meter will measure the total time that the device was turned on. Participants will also record use of the light in a log.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGSix-Minute Walk Distance
Four month change in six-minute walk distance
Time frame: Measured at baseline and 4 month follow-up
Walking Impairment Questionnaire Distance (WIQ) Score
Four month change in the WIQ distance score. Score range 0-100, 100 is best
Time frame: Measured at baseline and 4 month follow-up
Six-Minute Walk Distance
Acute change in six-minute walk distance after first light therapy
Time frame: Measured immediately after the first light treatment (within 15 minutes after the first treatment, acute effect)
Six-minute walk distance.
Four month change in 6-minute walk, measured 24 hours after last treatment.
Time frame: Measured at 4-month follow-up, 24 hours after the final treatment.
Calf muscle perfusion
Changes in calf muscle perfusion at 3 Tesla measured with arterial spin labeling with MRI and post-cuff occlusion hyperemia
Time frame: Measured at baseline and four-month follow up
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