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

Sponsor

Sanifit Therapeutics S. A. (Other)

Overall Status

Completed

CT.gov ID

NCT04487301

Collaborator

(none)

Enrollment

Locations

6.8

Actual Duration (Months)

5.1

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease End Stage Renal Disease on Dialysis

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Nov 16, 2020

Actual Primary Completion Date :

Jun 12, 2021

Actual Study Completion Date :

Jun 12, 2021

Outcome Measures

Primary Outcome Measures

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
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
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
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
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.
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.
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.
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
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	St Louis Kidney Care	Saint Louis	Missouri	United States	63136
6	Mountain Kidney & Hypertension Associates	Asheville	North Carolina	United States	28801
7	Houston Medical Research	Houston	Texas	United States	77004