NCT06579651

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 29, 2024

Last Update Submit

August 29, 2024

Conditions

Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (1)

  • Nail fold capillary pattern changes in SSc patients

    baseline

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cross sectional

You may qualify if:

  • Adult SSc Patients

You may not qualify if:

  • \- 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).
  • Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Intravital MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, CardiovascularInvestigative Techniques

Central Study Contacts

Mennatullah Salaheldin

CONTACT

+201010616746mennasalaheldin88@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mennatullah Salaheldin Mohamed

Study Record Dates

First Submitted

August 29, 2024

First Posted

August 30, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

August 30, 2024

Record last verified: 2024-08