Ischemic Preconditioning Claudication Study

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03511157
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication; Ischemia Vascular; Peripheral Arterial Disease; Peripheral Vascular Disease	Other: Ischemic Preconditioning; Other: Control Group	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
• Actual Study Start Date: Jun 14, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Ischemic Preconditioning; See Ischemic Preconditioning Experimental group description
Sham Comparator: 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	Other: Control Group; See Control group description

Outcome Measures

Primary Outcome Measures

1. Peak walking time [2 weeks]

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

Secondary Outcome Measures

1. Muscle Fatigue [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 [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Durand, Assistant Professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT03511157
• Other Study ID Numbers: PRO00031772
• First Posted: Apr 27, 2018
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matthew Durand, Assistant Professor, Medical College of Wisconsin: ischemic preconditioning
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Intermittent Claudication; Ischemia

Study Results

No Results Posted as of Oct 21, 2021