Intensive Insulin Treatment and Ischemic Foot Ulcer

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

Sponsors

Lead Sponsor: Karolinska Institutet

Source Karolinska Institutet
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.

Overall Status Completed
Start Date January 1984
Completion Date June 2013
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ischemic Foot Ulcer Until hospitalization for ischemic foot ulcer or until 31 December 2011
Enrollment 91
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intensified insulin treatment

Description: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.

Arm Group Label: Intensified insulin treatment

Other Name: Monotard; Actrapid

Intervention Type: Drug

Intervention Name: Standard treatment

Description: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Arm Group Label: Standard treatment

Other Name: Premixed Insulin

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas Nyström, MD Principal Investigator Karolinska Institutet
Location
Facility:
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset | Stockholm, 118 83, Sweden
Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB | Stockholm, 118 83, Sweden
Location Countries

Sweden

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Karolinska Institutet

Investigator Full Name: Thomas Nystrom

Investigator Title: MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Intensified insulin treatment

Type: Experimental

Description: Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day

Label: Standard treatment

Type: Active Comparator

Description: Mixed Insulin (2-3 times a day)

Label: Healthy controls

Type: No Intervention

Description: These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov