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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 7
- 主要终点
- Activity Patterns
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
结局指标
主要结局
Activity Patterns
时间窗: 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.
Actigraphy measurements as 24 hour intervals of motion using an accelerometer device
San Diego Claudication Questionnaire
时间窗: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
Will categorize the subject's perception of the leg symptoms associated with PAD
Walking Impairment Questionnaire
时间窗: Administered once during Week 1 during subject's participation of up to 4 weeks.
Will evaluate the subjects personal perception of walking ability.
Toe Brachial Index
时间窗: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Compares blood pressure in upper extremities and lower extremities
PAD Quality of Life
时间窗: Administered once during Week 1 during subject's participation of up to 4 weeks.
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.
Six Minute Walk Test
时间窗: 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.
Walking distance in meters completed over a duration of 6 minutes
Pulse Wave Velocity - Sub-Study
时间窗: 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.
Measures arterial stiffness
Ankle Brachial Index
时间窗: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Compares blood pressure in upper extremities and lower extremities
EQ-SD-SL Health Questionnaire
时间窗: Administered once during Week 1 during subject's participation of up to 4 weeks
Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Flow-Mediated Dilation - Sub-Study
时间窗: 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.
Measures the ability of blood vessels to dilate
Lower limb calcification measurements
时间窗: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.
A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.
Nitroglycerin-Medicated Dilation - Sub-Study
时间窗: 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.
Measures the ability of blood vessels to dilate after administration of nitroglycerin
次要结局
未报告次要终点