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Accuracy and reliability of the Ipswich Touch Test in identifying Loss of Protective Sensation among diabetic patients.

Completed
Conditions
diabetes mellitus
diabetes mellitus, protective sensation, Ipswich touch test
Registration Number
TCTR20230127004
Lead Sponsor
Chulalongkorn University
Brief Summary

The Ipswich touch test demonstrated a good diagnostic accuracy, with a sensitivity of 70.8%, specificity of 98.6%, and an area under the curve of 0.85 when compared to 10-g monofilament. Positive and negative predictive values were 94.4% and 90.8% respectively. The positive likelihood ratio was 49.82, and the negative likelihood ratio was 0.30. Interrater reliability, assessed with two raters in a subset of 93 participants, yielded a kappa of 0.88, indicating almost perfect agreement.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
283
Inclusion Criteria

1. type 1 or type 2 DM
2. interested in participating in this study

Exclusion Criteria

1. active foot ulceration in the assessed area
2. any kind of lower extremity amputation
3. non-diabetic causes of the insensate foot such as sequelae of cerebrovascular disease, lumbosacral radiculopathy, or peripheral neuropathy of an origin other than diabetes (i.e., Guillain-Barre Syndrome, malignancy, chronic kidney disease, cirrhosis, hypothyroidism, or were taking neurotoxic)

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Accuracy one time point Ipswich touch test
Secondary Outcome Measures
NameTimeMethod
Reliability one time point Ipswich touch test
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