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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00700362 |
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Date of registration:
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16/06/2008 |
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Primary sponsor: |
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Public title:
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Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)
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Scientific title:
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The Effect of Insulin-Glucose Infusion on Metabolic Control (Primary) and Inflammation (Secondary) in Diabetic Patients Treated for Acute Foot Ulcer Infection or Surgical Wound Infection |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00700362 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Kerstin Brismar, 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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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients are eligible for inclusion if the following criteria are fulfilled:
- Postoperative or infectious patients with: skin-, airways-, urine tract- or
gastro-intestinal infections.
- Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
- Older than 18 years.
- Informed consent obtained.
Exclusion Criteria:
Patients having any of the following at randomization will not be included in the study:
- Unconsciousness: not possible to wake up.
- Ketoacidosis: pH less or equal to 7.30.
- Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
- Kidney failure: calculated GFR < 30 mL/min.
- Pregnancy.
- Mental condition making the subject unable to understand the concepts and risk of the
study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Hyperglycemia
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Infection
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Insulin Resistance
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Intervention(s)
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Procedure: Insulin infusion (aspart)
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Procedure: Standard care
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Primary Outcome(s)
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Plasma glucose level.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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HbA1c
[Time Frame: 4 weeks]
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Hospital stay
[Time Frame: 4 weeks]
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laboratories for inflammation and oxidative stress.
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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