Intensive Insulin Treatment and Ischemic Foot Ulcer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957930
• Other study ID #: EPI-2012
• Status: Completed
• Phase: N/A
• Start date: January 1984
• Est. completion date: June 2013

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foot Ulcer
• Ischemia
• Ischemic Foot Ulcer
• Ulcer

Intervention

Drug:
• Intensified 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.
• Standard treatment
Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset	Stockholm
Sweden	Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Reichard P, Britz A, Cars I, Nilsson BY, Sobocinsky-Olsson B, Rosenqvist U. The Stockholm Diabetes Intervention Study (SDIS): 18 months' results. Acta Med Scand. 1988;224(2):115-22. — View Citation

Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993 Jul 29;329(5):304-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	7 years
Primary	Ischemic Foot Ulcer	The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code	Until hospitalization for ischemic foot ulcer or until 31 December 2011