A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis

Conditions
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Peripheral Artery Disease, End Stage Renal Disease on Dialysis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥55 years of age or ≥45 years of age with diabetes Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening Resting ABI <0.90 in either leg OR Resting TBI <0.70 in either leg Symptomatic as characterized by a limitation in exercise performance Exclusion Criteria: Above-ankle amputation Chronic limb-threatening ischemia (Rutherford 4-6) Non-ambulatory status A condition other than PAD that limits ability to walk Open or endovascular revascularization within 3 months prior to baseline. Illnesses, conditions, or planned surgeries within the study period that will interfere with the interpretation of the study results

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test | Walking distance in meters completed over a duration of 6 minutes | 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 | 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 | 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 | 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 | 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. | 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. | 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. | Administered once during Week 1 during subject's participation of up to 4 weeks | 
| Pulse Wave Velocity - Sub-Study | Measures arterial stiffness | 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 | 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 | 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. | Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, Dialysis, Peripheral Artery Disease, End Stage Kidney Disease, End Stage Renal Disease