Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)
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.
|Diabetes Mellitus Insulin Resistance Hyperglycemia Infection||Procedure: Insulin infusion (aspart) Procedure: Standard care||Phase 4|
|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|
- 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 ]
|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)|
Procedure: Insulin infusion (aspart)
Please refer to this study by its ClinicalTrials.gov identifier: 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|