Systemic SclerosisNCT06291142
Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot
An observational study of Systemic Sclerosis and Raynaud Phenomenon, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Raynaud Phenomenon
- What is being tested?
- Observation - Nailfold capillaroscopy
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2023to 31 Dec 2024
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be identified by a review of patient medical records, or patients who present at a clinic appointment. Healthy controls (only applicable to the skin tone study at Salford Royal) will be identified via a database of previous volunteers, and via advertisements. Rheumatologists, vascular technicians, specialist nurses and other associated professionals required to take part in the focus groups and interviews will likely be those from each of the collaborating sites. They will be informed of the opportunity to take part during meetings with the research team and will be sent a participant information sheet via email.
Who may be able to join
- Image Acquisition:
- Children (aged between 6-17 years) and adults (aged 18 years and above) with Raynaud's phenomenon or a SSc- spectrum disorder.
- Qualitative aspect:
- Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology trained professionals
- Patients with Raynaud's phenomenon and/or a SSc-spectrum disorder.
- Adults ages 18 years and over.
Who cannot join
- (Patients; image acquisition and skin tone study). Diabetes
- (Healthy controls). Requirement for vasoactive therapies
- (Healthy controls). Any condition known to affect the vasculature e.g. unregulated hypertension
- (All groups). Any disorder limiting the ability to provide informed consent or to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern Care Alliance NHS Foundation Trust
Salford, Salford, M6 8HD
About this study
Official title: NIHR i4i 2: Early Diagnosis of Systemic Sclerosis in the General Rheumatology Clinic - Pilot Image Acquisition Study
The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:
- Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
- Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
- Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.
Read more
Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.
Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.
Read the detailed description
Systemic sclerosis (SSc) is a painful, disabling disease affecting around 20,000 people in the UK. Symptoms include painful ulcers on the fingers and toes, sometimes requiring amputation, and life-threatening internal organ damage. The first symptom of SSc is usually Raynaud's phenomenon - white, painful fingers in the cold - though around 5% of otherwise healthy individuals also experience Raynaud's. The National Institute for Health and Care Excellence (NICE) recommends that GPs should refer patients with Raynaud's to a general rheumatology clinic for assessment. When a patient is referred for assessment, using nailfold capillaroscopy to find vessel abnormalities caused by SSc is recognised internationally as key to early diagnosis. Despite this, it is not used in most rheumatology clinics, because it requires expensive equipment and specialised skill. When capillaroscopy is not available, diagnosis is often delayed, which can have serious consequences for patients.
The research team will develop an artificial intelligence (AI) system that helps rheumatology clinics diagnose SSc as early as possible. The system will use nailfold capillaroscopy images of the small blood vessels at the base of the fingernails and digital technology to find changes due to disease. In a previous study has shown that, in expert hands, capillaroscopy images good enough to diagnose SSc can be obtained using a commercially available, hand-held microscope. The investigators have also developed AI image analysis software that finds capillary abnormalities very reliably.
This study will establish if target users can acquire diagnostic-quality images in clinic and provide feedback to inform technology refinement. Images will be acquired using version one of our software from 105 patients across seven centres in England. The investigators will also run focus groups and interviews to gain qualitative input from users and patients to assess usability of the system. The results of this study will contribute to the development of a complete system suitable for use by non-specialists.
- Conditions
- Systemic Sclerosis, Raynaud Phenomenon
- Being tested
- Observation - Nailfold capillaroscopy
- Keywords
- Raynaud's, Systemic Sclerosis Spectrum Disorder, Artificial Intelligence, Imaging, Capillaroscopy, Scleroderma
- Medical subject headings
- Scleroderma, Systemic, Raynaud Disease, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation - Nailfold capillaroscopyDevice
Nailfold capillaroscopy examination
| Study group | Role | What they receive |
|---|---|---|
| Patient Participants | Patients with an SSc spectrum disorder, and healthy controls (objective 3) Receives: Device: Observation - Nailfold capillaroscopy | |
| Healthcare Professional Participants | Healthcare Professionals taking part in the qualitative element of the study Receives: Device: Observation - Nailfold capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot Image Acquisition
A set of nailfold capillaroscopy images from each participant
Measured: 11 months
Secondary outcomes (2)
Qualitative Feedback
A set of qualitative feedback data collected from patient participants and HCPs
Measured: 11 months
Skin tone sub-study data set
A set of nailfold capillaroscopy images collected from participants from a range of Fitzpatrick Skin Scores, using 4 different light wavelength cameras
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start22 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of ManchesterThe 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 only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Bolton Hospital NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, University Hospitals of Morecambe Bay NHS Trust, Stockport NHS Foundation Trust, Medway NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ariane E Herrick, MD, FRCP, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291142
- Sponsor's protocol ID
- R129030
- Other IDs
- IRAS 315004
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrick AL, Berks M, Taylor CJ. Quantitative nailfold capillaroscopy-update and possible next steps. Rheumatology (Oxford). 2021 May 14;60(5):2054-2065. doi: 10.1093/rheumatology/keab006.
PubMed 33493310
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIHR i4i 2: Early Diagnosis of Systemic Sclerosis in the General Rheumatology Clinic - Pilot Image Acquisition Study
- ClinicalTrials.gov ID
- NCT06291142
- Acronym / sponsor ID
- R129030
- Conditions
- Systemic Sclerosis, Raynaud Phenomenon
- Keywords
- Raynaud's, Systemic Sclerosis Spectrum Disorder, Artificial Intelligence, Imaging, Capillaroscopy, Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Bolton Hospital NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, University Hospitals of Morecambe Bay NHS Trust, Stockport NHS Foundation Trust, Medway NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Mar 2024 (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.
The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:
- Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
- Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
- Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.
Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.
Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.
Detailed description
Systemic sclerosis (SSc) is a painful, disabling disease affecting around 20,000 people in the UK. Symptoms include painful ulcers on the fingers and toes, sometimes requiring amputation, and life-threatening internal organ damage. The first symptom of SSc is usually Raynaud's phenomenon - white, painful fingers in the cold - though around 5% of otherwise healthy individuals also experience Raynaud's. The National Institute for Health and Care Excellence (NICE) recommends that GPs should refer patients with Raynaud's to a general rheumatology clinic for assessment. When a patient is referred for assessment, using nailfold capillaroscopy to find vessel abnormalities caused by SSc is recognised internationally as key to early diagnosis. Despite this, it is not used in most rheumatology clinics, because it requires expensive equipment and specialised skill. When capillaroscopy is not available, diagnosis is often delayed, which can have serious consequences for patients.
The research team will develop an artificial intelligence (AI) system that helps rheumatology clinics diagnose SSc as early as possible. The system will use nailfold capillaroscopy images of the small blood vessels at the base of the fingernails and digital technology to find changes due to disease. In a previous study has shown that, in expert hands, capillaroscopy images good enough to diagnose SSc can be obtained using a commercially available, hand-held microscope. The investigators have also developed AI image analysis software that finds capillary abnormalities very reliably.
This study will establish if target users can acquire diagnostic-quality images in clinic and provide feedback to inform technology refinement. Images will be acquired using version one of our software from 105 patients across seven centres in England. The investigators will also run focus groups and interviews to gain qualitative input from users and patients to assess usability of the system. The results of this study will contribute to the development of a complete system suitable for use by non-specialists.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Participants | – | Device: Observation - Nailfold capillaroscopyPatients with an SSc spectrum disorder, and healthy controls (objective 3) |
| Healthcare Professional Participants | – | Device: Observation - Nailfold capillaroscopyHealthcare Professionals taking part in the qualitative element of the study |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be identified by a review of patient medical records, or patients who present at a clinic appointment. Healthy controls (only applicable to the skin tone study at Salford Royal) will be identified via a database of previous volunteers, and via advertisements. Rheumatologists, vascular technicians, specialist nurses and other associated professionals required to take part in the focus groups and interviews will likely be those from each of the collaborating sites. They will be informed of the opportunity to take part during meetings with the research team and will be sent a participant information sheet via email.
Key inclusion criteria (6 listed)
- Children (aged between 6-17 years) and adults (aged 18 years and above) with Raynaud's phenomenon or a SSc- spectrum disorder.
- Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology trained professionals
- Patients with Raynaud's phenomenon and/or a SSc-spectrum disorder.
- Adults ages 18 years and over.
Key exclusion criteria (4 listed)
- (Patients; image acquisition and skin tone study). Diabetes
- (Healthy controls). Requirement for vasoactive therapies
- (Healthy controls). Any condition known to affect the vasculature e.g. unregulated hypertension
- (All groups). Any disorder limiting the ability to provide informed consent or to comply with study requirements.
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 |
|---|---|---|
| Observation - Nailfold capillaroscopyNailfold capillaroscopy examination | Device | Healthcare Professional Participants, Patient Participants |
Primary outcome
Pilot Image Acquisition
Time frame: 11 months
A set of nailfold capillaroscopy images from each participant
2 secondary outcomes
Qualitative Feedback
Time frame: 11 months
Skin tone sub-study data set
Time frame: 11 months
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 3 Apr 2025.
- Background: PubMed 33493310Herrick AL, Berks M, Taylor CJ. Quantitative nailfold capillaroscopy-update and possible next steps. Rheumatology (Oxford). 2021 May 14;60(5):2054-2065. doi: 10.1093/rheumatology/keab006.
- Individual participant dataSharing planned: No
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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.
Ariane E Herrick, MD, FRCP principal investigator
The University of Manchester
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 and Raynaud Phenomenon, run by University of Manchester at 1 site in United Kingdom.
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 6 inclusion and 4 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 3 Apr 2025. 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 United Kingdom. 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?
Pilot Image Acquisition (time frame: 11 months). 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 NCT06291142, which also lists 1 linked publication.
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 3 Apr 2025.