Far Red Light to Improve Functioning in PAD — LIGHT PAD  

Aging Clinical Trial

Official title: Far Red Light to Improve Functioning in PAD: The LIGHT PAD Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Aging
• Mobility Limitation
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Walking, Difficulty

• NCT number: NCT06165016
• Study type: Interventional
• Source: Northwestern University
• Contact: Mary McDermott, MD
• Phone: 13125036419
• Email: mdm608@northwestern.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Completion date: June 1, 2027