Intensive Insulin Treatment and Ischemic Foot Ulcer

N/ACompletedNCT01957930

Karolinska Institutet91 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Foot Ulcer

Interventions

Intensified insulin treatmentDRUG

The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.

Standard treatmentDRUG

Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Stockholm, Sweden

Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB

Stockholm, Sweden

Outcomes

Primary Outcomes

Ischemic Foot Ulcer

The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code

Time frame: Until hospitalization for ischemic foot ulcer or until 31 December 2011

Data from ClinicalTrials.gov

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