Status:
RECRUITING
Oxygen-guided Supervised Exercise Therapy
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Nebraska
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Li...
Detailed Description
The long-term goal of this research is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by developing conservative interventions. PAD ...
Eligibility Criteria
Inclusion
- At entry into the study, all subjects must:
- Be able to give written, informed consent
- Have documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging
- Demonstrate positive history of chronic claudication
- Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
Exclusion
- Any potential subjects will be excluded if they have:
- Rest pain or tissue loss due to PAD (Fontaine stage III and IV)
- Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06003855
Start Date
October 1 2023
End Date
December 31 2025
Last Update
October 16 2025
Active Locations (1)
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1
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850