Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)
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|ClinicalTrials.gov Identifier: NCT00700362|
Recruitment Status : Withdrawn (Local regulations)
First Posted : June 18, 2008
Last Update Posted : October 5, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
- 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.
- Plasma glucose level. [ Time Frame: 4 weeks ]
- Hospital stay [ Time Frame: 4 weeks ]
- HbA1c [ Time Frame: 4 weeks ]
- laboratories for inflammation and oxidative stress. [ Time Frame: 4 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT00700362
|Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology|
|Stockholm, Sweden, 171 76|
|Principal Investigator:||Kerstin Brismar, Professor||Karolinska Institutet|