Ischemic Preconditioning Claudication Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511157
• Other study ID #: PRO00031772
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: December 13, 2022

Study information

• Verified date: December 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Ischemia
• Ischemia Vascular
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Other:
• Ischemic Preconditioning
See Ischemic Preconditioning Experimental group description
• Control Group
See Control group description

Locations

Country	Name	City	State
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak walking time	Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.	2 weeks
Secondary	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.	2 weeks
Secondary	Claudication onset time	Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.	2 weeks