Ischemic Foot Ulcer
Conditions
Keywords
HbA1c, Iontophoresis, Intensified insulin treatment, Ischemic foot ulcer, Type 1 diabetes
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.
Interventions
DRUGIntensified insulin treatment
The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
DRUGStandard treatment
Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Endothelial Function | 7 years | Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) \[endothelial-dependent\], sodium nitroprusside (SNP) \[endothelial-independent\], and capsaicin \[C-nociceptive dependent\] vasculature response. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intensified Insulin Treatment Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. | 35 |
| Standard-treatment Continuing with routine diabetes care
Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months | 37 |
| Healthy Control Solely controls for the iontophoresis method and no intention to be followd-up. | 19 |
| Total | 91 |
Baseline characteristics
| Characteristic | Standard-treatment | Healthy Control | Intensified Insulin Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 19 Participants | 35 Participants | 91 Participants |
| Age, Continuous | 42 years | 38 years | 42 years | 42 years |
| Region of Enrollment Sweden | 37 participants | 19 participants | 35 participants | 72 participants |
| Sex: Female, Male Female | 22 Participants | 8 Participants | 21 Participants | 51 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 14 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 37 | 0 / 19 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 | 0 / 19 |
Outcome results
Primary
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
Population: Data for Healthy Controls was not collected for this Outcome Measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensified Insulin Treatment | Ischemic Foot Ulcer | 3 participants |
| Standard-treatment | Ischemic Foot Ulcer | 10 participants |
Other Pre-specified
Microvascular Endothelial Function
Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) \[endothelial-dependent\], sodium nitroprusside (SNP) \[endothelial-independent\], and capsaicin \[C-nociceptive dependent\] vasculature response.
Time frame: 7 years