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SMOKING AND PRESENCE OF FRANK'S SIGN

PRESENCE OF FRANK'S SIGN: A COMPARATIVE EVALUATION IN SMOKERS AND NON-SMOKERS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07427745
Enrollment
404
Registered
2026-02-23
Start date
2024-09-01
Completion date
2025-05-06
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Smoking ( Cigarette)

Keywords

Frank's sign, smoking, cardiovascular disease

Brief summary

In this study, the effect of cigarette smoking-one of the major risk factors for cardiovascular diseases-on the development of Frank's sign (DELC) was investigated. Rather than smoking status alone, cumulative smoking exposure was considered to cause vascular damage and thereby influence the formation of DELC. Consequently, these findings may enable family physicians and other clinicians to approach patients rapidly and non-invasively within the framework of preventive medicine.

Interventions

OTHERTo obtain bilateral ear photographs

Digital photographs obtained from both ears in a well-lit environment were evaluated by the study researchers. The presence of Frank's sign and its staging according to the Modified Patel-Lopez classification were confirmed by a positive assessment from at least two researchers

OTHERTo take a medical history

The participants' sociodemographic data, histories of chronic diseases, medication use, family histories, and smoking habits were recorded by the researchers via face-to-face interviews (average duration: 5 min)

Sponsors

Samsun University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 59 Years
Healthy volunteers
Yes

Inclusion criteria

* Individuals aged 40-59 years who presented to the relevant outpatient clinics were included in the study.

Exclusion criteria

* The

Design outcomes

Primary

MeasureTime frameDescription
Analysis of the relationship between DELC (diagonal earlobe crease) and smoking consumptionmaximum duration: 10 minutesThe presence of DELC as unilateral, bilateral, or absent was evaluated with respect to smoking status categorized as current, non-smoker, or former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values \< 0.05 were considered statistically significant.
Association between smoking and DELC stage in patients with unilateral and bilateral DELCmaximum duration: 10 minutesThe presence of unilateral and bilateral DELC in the right and/or left ear was assessed across smoking status groups defined as current, non-smoker, and former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values \< 0.05 were considered statistically significant.

Secondary

MeasureTime frameDescription
Relationship between the participants' chronic diseases, medication use, family history, and the presence of DELC (diagonal earlobe crease)maximum duration: 10 minutesThe presence of chronic diseases (hypertension, diabetes, hyperlipidemia, and cardiovascular diseases), obesity, history of angiography, medication use, and family history of cardiovascular diseases and premature death was evaluated in individuals with unilateral and bilateral DELC as well as in those without DELC (absent). Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values \< 0.05 were considered statistically significant.
Analysis of the relationship between DELC and the presence of cardiac/noncardiac diseases and medication usemaximum duration: 10 minutesDiseases and medications were categorized as cardiac and non-cardiac. In individuals with unilateral and bilateral DELC, as well as in those without DELC (absent), the presence of cardiac and non-cardiac diseases was first evaluated, followed by the presence of cardiac and non-cardiac medication use. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values \< 0.05 were considered statistically significant.
Demographic characteristics of the participantsmaximum duration: 10 minutesDemographic characteristics like sex, marital status and smoking status of the participants were evaluated

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTOROnur Öztürk

Amasya University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026