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

Peripheral Artery Disease Clinical Trial

Official title:

A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487301
• Other study ID #: SNFCT2020-07
• Status: Completed
• Start date: November 16, 2020
• Est. completion date: June 12, 2021

Study information

• Verified date: October 2021
• Source: Sanifit Therapeutics S. A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 12, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
United States	Mountain Kidney & Hypertension Associates	Asheville	North Carolina
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Horizon Medical Research	Coral Gables	Florida
United States	Houston Medical Research	Houston	Texas
United States	Valley Renal Medical Group	Northridge	California
United States	St Louis Kidney Care	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sanifit Therapeutics S. A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.