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Ischemic Preconditioning Claudication Study

Primary Purpose

Intermittent Claudication, Ischemia Vascular, Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Preconditioning
Control Group
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring ischemic preconditioning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. between ages of 18-80
  2. able to give informed consent
  3. presence of vascular disease with intermittent claudication

Exclusion Criteria:

  1. age < 18 or >80
  2. unable to give informed consent
  3. presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene
  4. pregnancy
  5. unable to walk on a treadmill
  6. unable to perform or tolerate ischemic preconditioning
  7. unable to follow commands
  8. exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI
  9. patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg
  10. history of major lower extremity amputation
  11. history of major psychiatric disorder
  12. history of uncontrolled hypertension

Sites / Locations

  • Froedtert and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ischemic Preconditioning

Control

Arm Description

A standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes.

The sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures

Outcomes

Primary Outcome Measures

Peak walking time
Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.

Secondary Outcome Measures

Muscle Fatigue
Subjects will perform muscle contractions for muscle groups of interest (knee extensors/flexors and dorsiflexors/plantarflexors). Contractions will be measured in newton-meters. The duration will be determined by the time subjects first feel pain and when the pain becomes too great to continue. The investigators will provide subjects with visual feedback on the monitor throughout the testing.
Claudication onset time
Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.

Full Information

First Posted
April 9, 2018
Last Updated
December 13, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03511157
Brief Title
Ischemic Preconditioning Claudication Study
Official Title
Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.
Detailed Description
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear. The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication. The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT. The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Ischemia Vascular, Peripheral Arterial Disease, Peripheral Vascular Disease
Keywords
ischemic preconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Preconditioning
Arm Type
Experimental
Arm Description
A standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
The sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures
Intervention Type
Other
Intervention Name(s)
Ischemic Preconditioning
Intervention Description
See Ischemic Preconditioning Experimental group description
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
See Control group description
Primary Outcome Measure Information:
Title
Peak walking time
Description
Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Muscle Fatigue
Description
Subjects will perform muscle contractions for muscle groups of interest (knee extensors/flexors and dorsiflexors/plantarflexors). Contractions will be measured in newton-meters. The duration will be determined by the time subjects first feel pain and when the pain becomes too great to continue. The investigators will provide subjects with visual feedback on the monitor throughout the testing.
Time Frame
2 weeks
Title
Claudication onset time
Description
Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between ages of 18-80 able to give informed consent presence of vascular disease with intermittent claudication Exclusion Criteria: age < 18 or >80 unable to give informed consent presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene pregnancy unable to walk on a treadmill unable to perform or tolerate ischemic preconditioning unable to follow commands exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg history of major lower extremity amputation history of major psychiatric disorder history of uncontrolled hypertension
Facility Information:
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ischemic Preconditioning Claudication Study

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