Phase
Condition
Atherosclerosis
Thrombosis
Aging
Treatment
Sham light therapy
Far red light therapy
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria.
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 anklebrachial index less than or equal to 0.90), or angiographic evidence of PAD definedas 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 eitherleg after the heel-rise test.
Exclusion
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 inthe previous three months
Major medical illness including lung disease requiring oxygen, Parkinson's disease,a life-threatening illness with life expectancy less than six months, or cancerrequiring treatment in the previous two years. [NOTE: potential participants maystill qualify if they have had treatment for an early stage cancer in the past twoyears and the prognosis is excellent, unless the cancer is located in the lowerextremities. Participants who require oxygen only at night may still qualify.]
Mini-Mental Status Examination (MMSE) score < 23
Non-English speaking
Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants willbecome eligible after the final study follow-up visit of the stem cell or genetherapy study so long as at least six months have passed since the finalintervention administration. After completing a supplement or drug therapy (otherthan stem cell or gene therapy), participants will be eligible after the final studyfollow-up visit as long as at least three months have passed since the finalintervention of the trial.]
Visual impairment that limits walking ability.
Six-minute walk distance of <400 feet or >1700 feet.
Participation in a supervised treadmill exercise program or a cardiac rehabilitationprogram in previous three months or planning to begin a supervised treadmillexercise program or a cardiac rehabilitation program in the next five months.
Unwilling to avoid red light therapy outside of study participation.
Baseline blood pressure <100/45.
In addition to the above criteria, investigator discretion will be used to determineif the trial is unsafe or not a good fit for the potential participant.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available

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