NCT07012655

Brief Summary

In the current study we aim to assess the macrovascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 1, 2025

Last Update Submit

June 8, 2026

Conditions

Keywords

systemic sclerosisDoppler Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Macro vascular involvement in systemic sclerosis patients

    Assess the macro vascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.

    day 1

Interventions

All study participants will undergo abdominal Ultrasound and Colour doppler ultrasound study of the superior and inferior mesenteric arteries and the resistance index and peak systolic velocity (cm/s) of radial and ulnar arteries measured by ultrasonography color Doppler with spectral wave analysis.

Eligibility Criteria

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

The study will include 50 participants: Group 1: 25 Adult Systemic sclerosis fulfilling the criteria for the diagnosis by American College of Rheumatology /European league against rheumatism 2013 classification criteria for systemic sclerosis. Group 2: 25 healthy matched controls.

You may qualify if:

  • Adult systemic sclerosis patients fulfilling the criteria for the diagnosis by American College of Rheumatology /European league against rheumatism 2013 classification criteria for systemic sclerosis, who accept to participate in the current study.

You may not qualify if:

  • Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, mixed connective tissue disease).
  • those who Refuse to participate in the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

Location

Related Publications (2)

  • Lescoat A, Coiffier G, Rouil A, Droitcourt C, Cazalets C, de Carlan M, Perdriger A, Jego P. Vascular Evaluation of the Hand by Power Doppler Ultrasonography and New Predictive Markers of Ischemic Digital Ulcers in Systemic Sclerosis: Results of a Prospective Pilot Study. Arthritis Care Res (Hoboken). 2017 Apr;69(4):543-551. doi: 10.1002/acr.22965. Epub 2017 Mar 3.

    PMID: 27390194BACKGROUND
  • Romano E, Rosa I, Fioretto BS, Matucci-Cerinic M, Manetti M. Increased Circulating Soluble Junctional Adhesion Molecules in Systemic Sclerosis: Association with Peripheral Microvascular Impairment. Life (Basel). 2022 Nov 4;12(11):1790. doi: 10.3390/life12111790.

    PMID: 36362943BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Sara Farrag, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Rheumatology and Rehabilitation

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

May 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 30, 2025

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations