Intensive Insulin Treatment and Ischemic Foot Ulcer

Not Applicable

Completed

Conditions: Ischemic Foot Ulcer

Interventions: Drug: Standard treatment
Drug: Intensified insulin treatment

Registration Number: NCT01957930

Lead Sponsor: Karolinska Institutet

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard treatment	Mixed Insulin (2-3 times a day)
Intensified insulin treatment	Intensified insulin treatment	Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day

Primary Outcome Measures

Name	Time	Method
Ischemic Foot Ulcer	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
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Stockholm, Sweden
Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB
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Stockholm, Sweden