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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: |
NCT03002116 |
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Date of registration:
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21/12/2016 |
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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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Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients
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Scientific title:
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Microwave Radiometry Thermometry for Non-invasive Diagnosis of Arterial Disease in Diabetic Patients With Suspected Critical Limb Ischemia: A Multi-centre Feasibility Study |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03002116 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. 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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Greece
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United Kingdom
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Contacts
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Name:
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Elias Brountzos, MD, 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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ATTIKO University General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients suffering from both insulin and not insulin dependent diabetes mellitus.
- Critical limb ischemia verified by both clinical examination, haemodynamic tests and
digital subtraction angiography.
Exclusion Criteria:
- Uncertainty regarding the absence of peripheral arterial disease in groups N and DN.
- Uncertainty regarding the diagnosis of critical limb ischemia for patients in groups
DC and NDC.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ischaemic Neuropathy
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Peripheral Arterial Disease
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Diabetic Foot
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Intervention(s)
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Other: Tissue thermometry using non-invasive microwave radiometry device
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Primary Outcome(s)
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Mean foot tissue temperature
[Time Frame: 15 minutes]
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Secondary ID(s)
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EB? 1310/10-2-16
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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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