SMOKING AND PRESENCE OF FRANK'S SIGN

NCT07427745 | Completed

• 1 other identifier: 2024/11/1
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking ( Cigarette); Cardiovascular Disease

Keywords

Frank's sign; smoking; cardiovascular disease

Outcome Measures

Primary Outcomes (2)

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

  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.

  maximum duration: 10 minutes

• Association between smoking and DELC stage in patients with unilateral and bilateral DELC

  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.

  maximum duration: 10 minutes

Secondary Outcomes (3)

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

  maximum duration: 10 minutes

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

  maximum duration: 10 minutes

• Demographic characteristics of the participants

  maximum duration: 10 minutes

Study Arms (2)

smokers

Smoking individuals aged between 40 and 59 years.

Other: To obtain bilateral ear photographs; Other: To take a medical history

non-smokers (control group)

Individuals aged between 40 and 59 years who do not smoke

Other: To obtain bilateral ear photographs; Other: To take a medical history

Interventions

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

non-smokers (control group); smokers

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)

non-smokers (control group); smokers

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of all individuals aged 40-59 years presenting to the clinics of the Department of Family Medicine at Samsun University Faculty of Medicine (Smoking Cessation, Family Medicine, Traditional and Complementary Medicine, Home Health Services, and Obesity Clinics)

You may qualify if:

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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Training and Research Hospital (Samsun City Hospital)

Samsun, Turkey (Türkiye)

Location

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Related Links

• 3\. T.C. Sağlık Bakanlığı. Sağlık istatistikleri yıllığı 2023 \[Internet\]. Ankara: Sağlık Bilgi Sistemleri Genel Müdürlüğü; 2025 \[cited 2025 Apr 4\].

MeSH Terms

Conditions

Cigarette Smoking; Cardiovascular Diseases; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Onur Öztürk

  Amasya University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 23, 2026
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 6, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

TU (1)