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Completed

NCT Number: NCT07427745

SMOKING AND PRESENCE OF FRANK'S SIGN

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.

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Key information

Conditions

Smoking ( Cigarette) Behavior Cardiovascular Disease Cardiovascular Diseases Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

40 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Training and Research Hospital (Samsun City Hospital)

Samsun, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The exclusion criteria included being outside the specified age range, the presence of an earring or piercing on the earlobe, a history of trauma affecting the integrity of the ear, the presence of soft tissue diseases, or ear malformations.

Treatment and study plan

To obtain bilateral ear photographs

Other

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

To take a medical history

Other

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)

Primary outcomes

  1. Analysis of the relationship between DELC (diagonal earlobe crease) and smoking consumption

    Time frame: maximum duration: 10 minutes

    The 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.

  2. Association between smoking and DELC stage in patients with unilateral and bilateral DELC

    Time frame: maximum duration: 10 minutes

    The 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 outcomes

  1. Relationship between the participants' chronic diseases, medication use, family history, and the presence of DELC (diagonal earlobe crease)

    Time frame: maximum duration: 10 minutes

    The 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.

  2. Analysis of the relationship between DELC and the presence of cardiac/noncardiac diseases and medication use

    Time frame: maximum duration: 10 minutes

    Diseases 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.

  3. Demographic characteristics of the participants

    Time frame: maximum duration: 10 minutes

    Demographic characteristics like sex, marital status and smoking status of the participants were evaluated

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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