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Ischemic Preconditioning Claudication Study

NCT ID: NCT03511157

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2022-12-13

Brief Summary

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This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.

Detailed Description

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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.

Conditions

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Intermittent Claudication Ischemia Vascular Peripheral Arterial Disease Peripheral Vascular Disease

Keywords

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ischemic preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ischemic Preconditioning

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.

Group Type EXPERIMENTAL

Ischemic Preconditioning

Intervention Type OTHER

See Ischemic Preconditioning Experimental group description

Control

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

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

See Control group description

Interventions

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Ischemic Preconditioning

See Ischemic Preconditioning Experimental group description

Intervention Type OTHER

Control Group

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Matthew Durand

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00031772

Identifier Type: -

Identifier Source: org_study_id