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Completed

NCT Number: NCT03511157

Ischemic Preconditioning Claudication Study

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

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Key information

Conditions

Intermittent Claudication Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Ischemia Vascular Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic Preconditioning

Other

See Ischemic Preconditioning Experimental group description

Control Group

Other

See Control group description

Primary outcomes

  1. Peak walking time

    Time frame: 2 weeks

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

Secondary outcomes

  1. Muscle Fatigue

    Time frame: 2 weeks

    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.

  2. Claudication onset time

    Time frame: 2 weeks

    Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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