Intensive Insulin Treatment and Ischemic Foot Ulcer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Ischemic Foot Ulcer

Intervention / Treatment
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* Drug: Intensified insulin treatment
* Drug: Standard treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic Foot Ulcer | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Iontophoresis, Intensified insulin treatment, Ischemic foot ulcer, Type 1 diabetes