Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00700362
• Other study ID #: IIIFU_00
• Status: Withdrawn
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Introduction:

Normoglycemia is important for the outcome of acute surgical and medical conditions. Different insulin infusions have been studied to achieve normoglycemia and have proved to be useful. Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin. Different insulin infusions have been studied to achieve normoglycemia but the biological and chemical effects of insulin infusions have not been studied during foot ulcer infection and surgical wound infection in patients with diabetes. Therefore, we aim to investigate the importance of normoglycemia for the optimal treatment during foot ulcer infection and surgical wound infection among diabetics.

Hypothesis:

Target controlled insulin infusion is more effective in reducing hyperglycemia, improve healing of inflammation and infection in diabetics compared to conventional antidiabetic therapy.

Study Design:

This is a randomized prospective, open controlled trial of target controlled insulin infusion vs conventional antidiabetic therapy in diabetic patients. Diabetics treated for foot ulcer infection or surgical wound infection, who met eligibility criteria and choose to participate will be included and randomized.

Duration of study:

The infusion starts when patients who met the eligibility criteria has signed the informed consent. The intervention group continues for tree 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.

Selection of patients:

Patients with diabetic foot ulcer infection or surgical wound infection will be enrolled. At least 90 patients will be included during a 24 month-enrollment period.

Treatment:

Eligible patients will be randomized to insulin infusion (group 1) for 3 days or therapy according to clinical practise (group 2).

Group 1 (intervention group):

The insulin infusion starts when the patient full fill the eligibility criteria and has signed the informed consent. It controls by regular capillary plasma glucose tests and continues for tree days. The infusion stop on the fourth day, the insulin demand is estimated from the last 24 infusion hours by a specific algorithm and divided to 2-4 equal mealtime doses of mixinsulin. The first mealtime dose is given to the breakfast on the fourth day and the infusion continues for another 2 hours where after it is stopped. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.

All patients will have a stop visit at the study end.

Patient assignment to treatment group:

Patients recruited in the clinic and hospital wards and meeting the eligibility criteria and has signed the informed consent will be randomized.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Foot Ulcer
• Hyperglycemia
• Infection
• Insulin Resistance

Intervention

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.
• Standard care
Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.

Locations

Country	Name	City	State
Sweden	Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose level.		4 weeks
Secondary	Hospital stay		4 weeks
Secondary	HbA1c		4 weeks
Secondary	laboratories for inflammation and oxidative stress.		4 weeks