Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288555
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-18
Brief Title:
Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care
Sponsor:
Ponlawat Hanchana MD
Organization:
PhraPhutthabat Hospital
Study Overview
Official Title:
Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes
The main question it aims to answer is
How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test
Participants underwent both the Ipswich touch test and the 10-g monofilament test
The main question it aims to answer is
How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test
Participants underwent both the Ipswich touch test and the 10-g monofilament test
Detailed Description:
BACKGROUND Diabetic foot a severe complication of diabetes significantly impairs the quality of life of affected individuals However it can be prevented through screening for loss of protective sensation in the foot Currently standard screening methods still require specialized equipment and trained medical professionals
OBJECTIVES The aim of this study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes
METHODS This diagnostic study with a cross-sectional design focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District Saraburi Province Participants underwent both the Ipswich touch test and the 10-g monofilament test Statistical analysis included evaluating sensitivity specificity negative predictive value positive predictive value negative likelihood ratio positive likelihood ratio and Cohens kappa statistic to assess the diagnostic reliability of the Ipswich touch test
OBJECTIVES The aim of this study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes
METHODS This diagnostic study with a cross-sectional design focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District Saraburi Province Participants underwent both the Ipswich touch test and the 10-g monofilament test Statistical analysis included evaluating sensitivity specificity negative predictive value positive predictive value negative likelihood ratio positive likelihood ratio and Cohens kappa statistic to assess the diagnostic reliability of the Ipswich touch test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None