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NCT Number: NCT06579651

Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.

Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

SSc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs.

Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.

Several studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that NVC abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. Furthermore, successful treatments have been shown to reduce NVC abnormalities in SSc cases, and these findings support the importance of NVC in monitoring SSc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials.

Three different NVC patterns of microvascular damage have been described ("early" , "active" , "late" ).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult SSc Patients

Exclusion criteria

  • 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).

3-Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.

Treatment and study plan

Nailfold videocapillaroscopy (NVC)

Device

Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.

Primary outcomes

  1. Nail fold capillary pattern changes in SSc patients

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Mennatullah Salaheldin

CONTACT

[email protected]

+201010616746

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

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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