Intensive Insulin Treatment and Ischemic Foot Ulcer

September 28, 2020 updated by: Thomas Nystrom, Karolinska Institutet

Intensified Insulin Treatment and Skin Microcirculation; Its Relation to Ischemic Foot Ulcer in Patients With Type 1 Diabetes Mellitus: A Long-term Follow-up Study

We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomiz (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present study, 96 patients from the SDIS study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35 vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). All participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

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, 118 83
        • Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
      • Stockholm, Sweden, 118 83
        • Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB

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 to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Born 1930 or later, Type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients.

Exclusion Criteria:

Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensified insulin treatment
Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day
Drug: Intensified insulin treatment
The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
Other Names:
  • Monotard; Actrapid
Active Comparator: Standard treatment
Mixed Insulin (2-3 times a day)
Drug: Standard treatment
Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Other Names:
  • Premixed Insulin
No Intervention: Healthy controls
These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic Foot Ulcer
Time Frame: Until hospitalization for ischemic foot ulcer or until 31 December 2011
The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code
Until hospitalization for ischemic foot ulcer or until 31 December 2011

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microvascular Endothelial Function
Time Frame: 7 years
Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.
7 years

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Thomas Nyström, MD, 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

January 1, 1984

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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