A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
Study Type
OBSERVATIONAL
Enrollment
36
Valley Renal Medical Group
Northridge, California, United States
Horizon Medical Research
Coral Gables, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Six Minute Walk Test
Walking distance in meters completed over a duration of 6 minutes
Time frame: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.
Activity Patterns
Actigraphy measurements as 24 hour intervals of motion using an accelerometer device
Time frame: Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.
Ankle Brachial Index
Compares blood pressure in upper extremities and lower extremities
Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Toe Brachial Index
Compares blood pressure in upper extremities and lower extremities
Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
San Diego Claudication Questionnaire
Will categorize the subject's perception of the leg symptoms associated with PAD
Time frame: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
Walking Impairment Questionnaire
Will evaluate the subjects personal perception of walking ability.
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
PAD Quality of Life
Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Louis Kidney Care
St Louis, Missouri, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, United States
Houston Medical Research
Houston, Texas, United States
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
EQ-SD-SL Health Questionnaire
Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks
Pulse Wave Velocity - Sub-Study
Measures arterial stiffness
Time frame: Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.
Flow-Mediated Dilation - Sub-Study
Measures the ability of blood vessels to dilate
Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Nitroglycerin-Medicated Dilation - Sub-Study
Measures the ability of blood vessels to dilate after administration of nitroglycerin
Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Lower limb calcification measurements
A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.
Time frame: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.