Intensive Insulin Treatment and Ischemic Foot Ulcer

NCT ID: NCT01957930

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1984-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

Ischemic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensified insulin treatment

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

Group Type: EXPERIMENTAL

Intensified insulin treatment

Intervention Type: DRUG

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

Mixed Insulin (2-3 times a day)

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: DRUG

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

Healthy controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Standard treatment

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

Intervention Type: DRUG

Other Intervention Names

Monotard; Actrapid; 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Thomas Nystrom

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Nyström, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Stockholm, , Sweden

Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB

Stockholm, , Sweden

Countries

Sweden

References

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. doi: 10.1111/j.0954-6820.1988.tb16748.x.

Reference Type: BACKGROUND

PMID: 3048052 (View on PubMed)

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. doi: 10.1056/NEJM199307293290502.

Reference Type: BACKGROUND

PMID: 8147960 (View on PubMed)

Rathsman B, Jensen-Urstad K, Nystrom T. Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study. Diabetologia. 2014 Aug;57(8):1703-10. doi: 10.1007/s00125-014-3248-2. Epub 2014 May 7.

Reference Type: DERIVED

PMID: 24802206 (View on PubMed)

Other Identifiers

EPI-2012

Identifier Type: -

Identifier Source: org_study_id