End Stage Renal Disease on Dialysis, Peripheral Artery Disease
Conditions
Keywords
PAD, Peripheral Artery Disease, End Stage Kidney Disease, End Stage Renal Disease, Dialysis
Brief summary
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.
Interventions
None listed
Sponsors
Sanifit Therapeutics S. A.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test | 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 |
| Activity Patterns | 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 |
| Ankle Brachial Index | 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 |
| Toe Brachial Index | 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 |
| San Diego Claudication Questionnaire | 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 | Administered once during Week 1 during subject's participation of up to 4 weeks. | Will evaluate the subjects personal perception of walking ability. |
| PAD Quality of Life | 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. |
| EQ-SD-SL Health Questionnaire | 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. |
| Pulse Wave Velocity - Sub-Study | 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 |
| Flow-Mediated Dilation - Sub-Study | 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 |
| Nitroglycerin-Medicated Dilation - Sub-Study | 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 |
| Lower limb calcification measurements | 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. |
Countries
United States
Outcome results
None listed