Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet Identifier:
First received: June 16, 2008
Last updated: April 8, 2015
Last verified: December 2011

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
Procedure: Insulin infusion (aspart)
Procedure: Standard care
Phase 4

Study Type: Observational
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:

Further study details as provided by Karolinska Institutet:

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

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

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00700362

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


Responsible Party: Mats Bonnier, MD, Karolinska Institutet Identifier: NCT00700362     History of Changes
Other Study ID Numbers: IIIFU_00
Study First Received: June 16, 2008
Last Updated: April 8, 2015

Keywords provided by Karolinska Institutet:
Insulin infusion

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Foot Ulcer
Surgical Wound Infection
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Wound Infection
Postoperative Complications
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 21, 2017