Intensive Insulin Treatment and Ischemic Foot Ulcer
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
Lead Sponsor: Karolinska Institutet
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.
|Start Date||January 1984|
|Completion Date||June 2013|
|Primary Completion Date||December 2011|
Intervention Type: Drug
Intervention Name: Intensified insulin treatment
Description: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
Arm Group Label: Intensified insulin treatment
Other Name: Monotard; Actrapid
Intervention Type: Drug
Intervention Name: Standard treatment
Description: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Arm Group Label: Standard treatment
Other Name: Premixed Insulin
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.
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.
Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.
Minimum Age: 18 Years
Maximum Age: 50 Years
Healthy Volunteers: Accepts Healthy Volunteers
Type: Principal Investigator
Investigator Affiliation: Karolinska Institutet
Investigator Full Name: Thomas Nystrom
Investigator Title: MD, PhD
|Has Expanded Access||No|
|Number Of Arms||3|
Label: Intensified insulin treatment
Description: Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day
Label: Standard treatment
Type: Active Comparator
Description: Mixed Insulin (2-3 times a day)
Label: Healthy controls
Type: No Intervention
Description: These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)