Ischemic Preconditioning Claudication Study

NCT03511157 | Completed DMC

• 1 other identifier: PRO00031772
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intermittent Claudication; Ischemia Vascular; Peripheral Arterial Disease; Peripheral Vascular Disease

Keywords

ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Peak walking time

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

  2 weeks

Secondary Outcomes (2)

• Muscle Fatigue

  2 weeks

• Claudication onset time

  2 weeks

Study Arms (2)

Ischemic Preconditioning

EXPERIMENTAL

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.

Other: Ischemic Preconditioning

Control

SHAM COMPARATOR

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

Other: Control Group

Interventions

Ischemic Preconditioning OTHER

See Ischemic Preconditioning Experimental group description

Ischemic Preconditioning

Control Group OTHER

See Control group description

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between ages of 18-80
• able to give informed consent
• presence of vascular disease with intermittent claudication

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease; Peripheral Vascular Diseases

Interventions

Ischemic Preconditioning; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 27, 2018
• Study Start: June 14, 2018
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)