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

Completed

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

• Registration Number: NCT04487301
• Lead Sponsor: Sanifit Therapeutics S. A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-11-16
• Primary Completion: 2021-06-12
• Study Completion: 2021-06-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.
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
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.
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
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
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.
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
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.
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

Trial Locations

Locations (7)

St Louis Kidney Care; 🇺🇸 Saint Louis, Missouri, United States

Horizon Medical Research; 🇺🇸 Coral Gables, Florida, United States

Valley Renal Medical Group; 🇺🇸 Northridge, California, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mountain Kidney & Hypertension Associates; 🇺🇸 Asheville, North Carolina, United States

Houston Medical Research; 🇺🇸 Houston, Texas, United States