Conditions: Ischemic Foot Ulcer
Keywords: HbA1c Iontophoresis Intensified insulin treatment Ischemic foot ulcer Type 1 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: yes

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.

Arms:
arm 1: Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day arm 2: Mixed Insulin (2-3 times a day) arm 3: These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-

Interventions: intervention 1: Intensified insulin treatment intervention 2: Standard treatment
Intervention descriptions: intervention 1: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. intervention 2: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Protocol document: