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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01707979
Other study ID # NIR
Secondary ID
Status Completed
Phase N/A
First received September 25, 2012
Last updated October 15, 2012
Start date September 2012
Est. completion date October 2012

Study information

Verified date October 2012
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
Study type Observational

Clinical Trial Summary

The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.


Description:

The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy.

The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years to 50 Years
Eligibility Inclusion Criteria:

- men with type 1 diabetes (WHO criteria)

- age 35-50 years

- duration of diabetes > 10 years

Exclusion Criteria:

- P-creatinine> 120 micromol/l

- other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator

- non intact skin on the measuring spots

- the patient is unable to understand the informed consent

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Steno Diabetes Center Gentofte

Sponsors (1)

Lead Sponsor Collaborator
Lise Tarnow

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary near infrared spectroscopy Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe one time No
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