Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
Study NCT ID:
NCT07271550
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-08-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NAFF Arabic Validation Study
Sponsor:
Faculty of Medicine, Sousse
Organization:
Study Overview
Official Title:
Cross-cultural Adaptation and Validation of the Nottingham Assessment of Functional Footcare (NAFF) Questionnaire Among Arabic-speaking Adults With Diabetes in Tunisia
Status:
COMPLETED
Status Verified Date:
2025-08
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:
This study aims to evaluate a new Arabic version of the NAFF questionnaire, which measures foot care behaviors in adults with type 2 diabetes. Participants are adults with type 2 diabetes who will complete the questionnaire online. The study will assess how reliable and valid the Arabic version is, helping healthcare providers identify risky foot care behaviors and improve patient education.
Detailed Description:
This study is a cross-sectional validation of the NAFF questionnaire translated into Arabic. Adult patients with type 2 diabetes will be recruited from endocrinology outpatient clinic in Sousse. Participants will complete the Arabic NAFF online. Primary outcomes include assessment of reliability (internal consistency, test-retest) and validity (construct and criterion validity). Secondary outcomes include the relationship between foot care behaviors and demographic or clinical factors. All participants will provide informed consent electronically. The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Sousse. Data will be analyzed using descriptive and inferential statistics to evaluate the psychometric properties of the Arabic NAFF..
Study Oversight
Has Oversight DMC:
False
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?: