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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03547817 |
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Date of registration:
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22/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
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Scientific title:
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Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease. An Experimental Study to Investigate the Optimal Pulse Pressure Regime to Improve Blood Flow. |
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Date of first enrolment:
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May 15, 2018 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03547817 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Jonny Hisdal, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Vascular diseases, Oslo University Hospital, Aker |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed peripheral artery disease
- Ankle-Brachial Index <0.9
Exclusion Criteria:
- Incapable to make an informed consent
- Diagnosis of severe psychiatric disease
- Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV),
severe valve failure
- Systemic infection
- Use of vasoactive substances
Age minimum:
18 Years
Age maximum:
96 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Intermittent Claudication
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Lower Extremity Claudication
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Peripheral Artery Disease
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Intervention(s)
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Device: Intermittent negative pressure device
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Primary Outcome(s)
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Arterial blood flow
[Time Frame: At time of intervention]
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Secondary Outcome(s)
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Skin blood flow
[Time Frame: At time of intervention]
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Secondary ID(s)
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SD0321063
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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