Ischemic Foot Ulcer Clinical Trial
Official title:
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00731835 -
Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone
|
N/A |