N/A
N=91
Intensive Insulin Treatment and Ischemic Foot Ulcer
Ischemic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01957930 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Ischemic Foot Ulcer — 3; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensified insulin treatment (Drug); Standard treatment (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ischemic Foot Ulcer |
3; 10 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01957930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.