Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

September 30, 2020 updated by: Mats Bonnier, Karolinska Institutet

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Office patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose level.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 4 weeks
4 weeks
Hospital stay
Time Frame: 4 weeks
4 weeks
laboratories for inflammation and oxidative stress.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIIFU_00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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