An observational study in Peripheral Artery Disease and End Stage Renal Disease on Dialysis, sponsored by Sanifit Therapeutics S. A.. Completed at 7 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by Sanifit Therapeutics S. A. · Observational
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 36 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Sanifit Therapeutics S. A. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community sample of PAD-ESKD subjects
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Sanifit Therapeutics S. A.