Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Community sample of PAD-ESKD subjects
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alex Gold, MD | Sanifit Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Renal Medical Group | Northridge | California | 91324 | United States | ||
| Horizon Medical Research |
Not provided
Not provided
Not provided
Not provided
| 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. |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| St Louis Kidney Care | St Louis | Missouri | 63136 | United States |
| Mountain Kidney & Hypertension Associates | Asheville | North Carolina | 28801 | United States |
| Houston Medical Research | Houston | Texas | 77004 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided