A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease

Sanifit

Status: Completed

Conditions: Peripheral Artery Disease; End Stage Renal Disease on Dialysis

Study type: Observational

Funder types: Other

Identifiers

NCT04487301

SNFCT2020-07

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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