Status:
COMPLETED
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
Lead Sponsor:
Sanifit Therapeutics S. A.
Conditions:
Peripheral Artery Disease
End Stage Renal Disease on Dialysis
Eligibility:
All Genders
45+ years
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-...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
November 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04487301
Start Date
November 16 2020
End Date
June 12 2021
Last Update
October 14 2021
Active Locations (7)
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1
Valley Renal Medical Group
Northridge, California, United States, 91324
2
Horizon Medical Research
Coral Gables, Florida, United States, 33134
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Boston Medical Center
Boston, Massachusetts, United States, 02118