Systemic SclerosisNCT07012655
Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis Patients
An observational study of Systemic Sclerosis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Colour Doppler Ultrasound
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, mixed connective tissue disease).
- those who Refuse to participate in the current study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Systemic sclerosis (SSc) is a connective tissue disease (CTD) characterized by diffuse cutaneous sclerosis of skin and organs, small vessel vasculopathy and immune system dysregulation associated with the production of autoantibodies.
Although small vessel vasculopathy can be considered a hallmark of this disease, large vessels can also be involved. Accordingly, involvement of medium vessels such as the ulnar artery has been evaluated in the literature, with results showing how ulnar artery occlusion (UAO) could be considered as a severity marker of vasculopathy as well as a predictive marker of digital ulcers (DUs), which are typically more frequent in patients with limited cutaneous (lc) SSc.
The gastrointestinal (GI) tract is one of the most frequently involved organs, affecting the majority (75-90%) of SSc patients.
GI involvement is often largely asymptomatic because it is frequently subclinical until severe tissue damage occurs. Once symptoms occur, SSc-related GI involvement heavily impacts morbidity and mortality, with patients experiencing significant emotional and social burdens and decreased survival in severe cases.
Unfortunately, the diagnosis of GI involvement is challenging because it is often delayed by the paucity of signs and symptoms early in the disease. Moreover, several diagnostic investigations that are useful in defning GI involvement are either invasive, expensive or not very informative.
Understanding the etiology and early phases of GI involvement, therefore, remains a high priority in SSc research. The aim would be to identify patients at high risk of developing progressive GI involvement, monitor disease activity, in the vessels or other relevant tissues, and intervene before the development of signifcant damage/dysfunction.
Bandini et al. showed how potentially the splanchnic vessels in SSc may be non-invasively investigated with abdominal US and color Doppler US, showing that some morphological and functional US parameters of mesenteric arteries of SSc patients are different from healthy controls defining a "bowel vasculopathy".
Abdominal ultrasound (US) is a unique tool that allows for the noninvasive assessment of the vasculature and major parts of the GI tract, including extra-intestinal features and splanchnic vessels as well as peripheral vessels.
- Conditions
- Systemic Sclerosis
- Being tested
- Colour Doppler Ultrasound
- Keywords
- systemic sclerosis, Doppler Ultrasound
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colour Doppler UltrasoundDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 May 2024
- Primary completion1 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Farrag Ahmed Mohamed, Assiut University
- Investigators
- Sara Farrag, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012655
- Sponsor's protocol ID
- SFA12025
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27390194Romano 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.
PubMed 36362943
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07012655
- Acronym / sponsor ID
- SFA12025
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, Doppler Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Systemic sclerosis (SSc) is a connective tissue disease (CTD) characterized by diffuse cutaneous sclerosis of skin and organs, small vessel vasculopathy and immune system dysregulation associated with the production of autoantibodies.
Although small vessel vasculopathy can be considered a hallmark of this disease, large vessels can also be involved. Accordingly, involvement of medium vessels such as the ulnar artery has been evaluated in the literature, with results showing how ulnar artery occlusion (UAO) could be considered as a severity marker of vasculopathy as well as a predictive marker of digital ulcers (DUs), which are typically more frequent in patients with limited cutaneous (lc) SSc.
The gastrointestinal (GI) tract is one of the most frequently involved organs, affecting the majority (75-90%) of SSc patients.
GI involvement is often largely asymptomatic because it is frequently subclinical until severe tissue damage occurs. Once symptoms occur, SSc-related GI involvement heavily impacts morbidity and mortality, with patients experiencing significant emotional and social burdens and decreased survival in severe cases.
Unfortunately, the diagnosis of GI involvement is challenging because it is often delayed by the paucity of signs and symptoms early in the disease. Moreover, several diagnostic investigations that are useful in defning GI involvement are either invasive, expensive or not very informative.
Understanding the etiology and early phases of GI involvement, therefore, remains a high priority in SSc research. The aim would be to identify patients at high risk of developing progressive GI involvement, monitor disease activity, in the vessels or other relevant tissues, and intervene before the development of signifcant damage/dysfunction.
Bandini et al. showed how potentially the splanchnic vessels in SSc may be non-invasively investigated with abdominal US and color Doppler US, showing that some morphological and functional US parameters of mesenteric arteries of SSc patients are different from healthy controls defining a "bowel vasculopathy".
Abdominal ultrasound (US) is a unique tool that allows for the noninvasive assessment of the vasculature and major parts of the GI tract, including extra-intestinal features and splanchnic vessels as well as peripheral vessels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, mixed connective tissue disease).
- those who Refuse to participate in the current study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colour Doppler UltrasoundAll 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. | Device | – |
Primary outcome
Macro vascular involvement in systemic sclerosis patients
Time frame: day 1
Assess the macro vascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 27390194Lescoat 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.
- Background: PubMed 36362943Romano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Farrag, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macro vascular involvement in systemic sclerosis patients (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.