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Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

This study has been withdrawn prior to enrollment.
(This study is a part of the IINDU study)
Sponsor:
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00700362
First received: June 16, 2008
Last updated: December 4, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus
Insulin Resistance
Hyperglycemia
Infection
 Procedure: Insulin infusion (aspart)
Procedure: Standard care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Plasma glucose level. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • laboratories for inflammation and oxidative stress. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700362

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

Publications:

Responsible Party: Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00700362     History of Changes
Other Study ID Numbers: IIIFU_00
Study First Received: June 16, 2008
Last Updated: December 4, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Complications
Hyperglycemia
Insulin infusion

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Insulin Resistance
Surgical Wound Infection
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Wound Infection
Infection
 Postoperative Complications
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013