Intensive Insulin Treatment and Ischemic Foot Ulcer

Karolinska Institute

Status: Completed

Conditions: Ischemic Foot Ulcer

Treatments: Drug: Standard treatment; Drug: Intensified insulin treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01957930

EPI-2012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Intensified insulin treatment

Experimental group

Description:

Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day

Treatment:

Drug: Intensified insulin treatment

Standard treatment

Active Comparator group

Description:

Mixed Insulin (2-3 times a day)

Treatment:

Drug: Standard treatment

Healthy controls

No Intervention group

Description:

These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-