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Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

NCT00700362 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-10-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kerstin Brismar, Professor · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700362 on ClinicalTrials.gov