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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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16 December 2017 |
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Main ID: |
NCT02273232 |
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Date of registration:
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18/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial
RIPC-PVD |
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Scientific title:
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Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02273232 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Stewart E Walsh, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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NUIG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Known moderate PVD
2. New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms
Exclusion Criteria:
1. Known upper limb PVD
2. Severe cardiac condition
3. Risk classification for exercise training: class C and above
4. Severe respiratory condition
5. Previous history of upper limb deep vein thrombosis
6. Patients on glibenclamide or nicorandil- May affect RIPC
7. Raynaud's Disease
8. Contra indications for MRA
9. Pregnancy
10. Previous major limb amputation affect ability to exercise
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Arterial Diseases
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Intervention(s)
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Other: Remote Ischemic Preconditioning
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Other: Standard Care
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Other: Supervised Exercise
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Primary Outcome(s)
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EQ-5D quality of life measures
[Time Frame: 6 months]
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Symptoms free distance
[Time Frame: 30 days]
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6-minute walk test
[Time Frame: 30 days]
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ABI -Ankle-Brachial Index Test
[Time Frame: 30 days]
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Secondary Outcome(s)
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Effects on BP (Blood Pressure )
[Time Frame: 30 days]
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Progression of Rutherford classification
[Time Frame: 30 days]
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Minor amputations
[Time Frame: 30 days]
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Progress for amputation during trial
[Time Frame: 30 days]
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% changes in ABI
[Time Frame: 30 days]
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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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