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Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700362
Recruitment Status : Withdrawn (Local regulations)
First Posted : June 18, 2008
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet

Brief Summary:

Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during foot ulcer infection and surgical wound infection.

  • The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during foot ulcer infection and surgical wound infection.
  • Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.

Condition or disease Intervention/treatment
Diabetes Mellitus Insulin Resistance Hyperglycemia Infection Procedure: Insulin infusion (aspart) Procedure: Standard care

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2011
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Intervention Details:
  • Procedure: Insulin infusion (aspart)
    The insulin infusion, a fast acting insulin analog (aspart) in 1 Unit/ml of NaCl, starts when the patients full fill the eligibility criteria and has signed the informed consent. The intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
  • Procedure: Standard care
    Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.

Primary Outcome Measures :
  1. Plasma glucose level. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: 4 weeks ]
  2. HbA1c [ Time Frame: 4 weeks ]
  3. laboratories for inflammation and oxidative stress. [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Office patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700362

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Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Kerstin Brismar, Professor Karolinska Institutet

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Responsible Party: Mats Bonnier, MD, Karolinska Institutet Identifier: NCT00700362    
Other Study ID Numbers: IIIFU_00
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Keywords provided by Mats Bonnier, Karolinska Institutet:
Insulin infusion
Additional relevant MeSH terms:
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Foot Ulcer
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Hypoglycemic Agents
Physiological Effects of Drugs