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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

⁃ First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Mary McDermott, MD
mdm608@northwestern.edu
13125036419
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 32
Treatments
Experimental: Far red light therapy
Subgroup of participants receiving the 670 nm far red light device
Sham_comparator: Sham therapy
Subgroup of participants receiving the sham light device, far red light device covered with blue filter paper to block 670 nm light, resulting in mean power generated of 0.24 mW/cm2, compared to 26.3 mW/cm2 for the intervention, a 100-fold difference.
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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