Trial Outcomes & Findings for Intensive Insulin Treatment and Ischemic Foot Ulcer (NCT NCT01957930)

NCT ID: NCT01957930

Last Updated: 2020-09-29

Results Overview

The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: Until hospitalization for ischemic foot ulcer or until 31 December 2011
• Results posted on: 2020-09-29

Participant Flow

Participant milestones

Measure	Intensified Insulin Treatment Intensified conventional 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 Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months	Healthy Controls 19 healthy controls were invited to compare microcirculation between healthy and diabetes individuals
Overall Study STARTED	35	37	19
Overall Study COMPLETED	35	37	19
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intensive Insulin Treatment and Ischemic Foot Ulcer

Baseline characteristics by cohort

Measure	Intensified Insulin Treatment n=35 Participants Intensified conventional 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 n=37 Participants Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months	Healthy Control n=19 Participants Solely controls for the iontophoresis method and no intention to be followd-up.	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	37 Participants n=7 Participants	19 Participants n=5 Participants	91 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	42 years n=5 Participants	42 years n=7 Participants	38 years n=5 Participants	42 years n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment Sweden	35 participants n=5 Participants	37 participants n=7 Participants	19 participants n=5 Participants	72 participants n=4 Participants

PRIMARY outcome

Timeframe: Until hospitalization for ischemic foot ulcer or until 31 December 2011

Population: Data for Healthy Controls was not collected for this Outcome Measure.

The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code

Outcome measures

Measure	Intensified Insulin Treatment n=35 Participants Intensified conventional 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 n=37 Participants Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Ischemic Foot Ulcer	3 participants	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 years

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.

Outcome measures

Outcome data not reported

Adverse Events

Intensified Insulin Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intensified Insulin Treatment n=35 participants at risk Intensified conventional 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 n=37 participants at risk Continuing with routine diabetes care Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months	Healthy Controls n=19 participants at risk These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up.
Blood and lymphatic system disorders 0	0.00% 0/35	0.00% 0/37	0.00% 0/19

Other adverse events

Adverse event data not reported

Additional Information

Thomas Nyström

Karolinska Institutet Södersjukhuset

Phone: +46704325214

Email: thomas.nystrom@sodersjukhuset.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place