A multi-centre study testing a new imaging app to help diagnose systemic sclerosis using nailfold capillaroscopy
| ISRCTN | ISRCTN72585279 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72585279 |
| Integrated Research Application System (IRAS) | 324900 |
| Central Portfolio Management System (CPMS) | 70207 |
| National Institute for Health and Care Research (NIHR) | 204551 |
| Sponsor | University of Manchester |
| Funder | National Institute for Health and Care Research |
- Submission date
- 11/11/2025
- Registration date
- 27/11/2025
- Last edited
- 27/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study is testing a new software system called CapilyticsAcquisition, which helps healthcare professionals take and analyse images of the tiny blood vessels near the fingernails, a technique known as nailfold capillaroscopy. These images can help doctors assess conditions like Raynaud’s phenomenon and systemic sclerosis (SSc).
The Capilytics system is designed to support non-specialist users in general rheumatology clinics by guiding them to collect high-quality images and automatically generating reports that may assist in diagnosis and treatment decisions.
The study aims to check that the CapilyticsAcquisition system works as intended, identify any risks or side effects, and gather feedback to refine the software and improve its usability.
Who can participate?
Participants in the study will include adults and children aged 6 and over who are being assessed for Raynaud’s or SSc.
What does the study involve?
After giving consent, participants will complete a short questionnaire and have their nailfold capillaries imaged using the CapilyticsAcquisition system. This may happen during a regular clinic visit or a dedicated study appointment.
Once the images are taken, they will be securely uploaded to servers at The University of Manchester. The system will then automatically analyse the images and generate a clinical report. Before seeing the full report, the clinician will review a sample of the images and give their own assessment of the patient’s condition and treatment plan. They will then view the full report and provide feedback on how useful it is.
After the imaging session, both participants and clinicians will complete questionnaires about their experience. Some participants and all healthcare professionals will also be invited to take part in interviews or group discussions to help improve the system.
What are the possible benefits and risks of participating?
Possible Benefits
Taking part in this study may help improve future care for people with Raynaud’s phenomenon and SSc. By testing a new imaging and analysis system, the research could make it easier for hospitals to offer nailfold capillaroscopy and help doctors diagnose these conditions earlier and more accurately. While the report from the software will not affect the treatment of those taking part in the study, their participation will contribute to developing technology that could benefit others in the future.
Possible Risks
The procedure is very low risk and involves taking pictures of the small blood vessels at the base of the fingernails. Some participants may feel mild discomfort from keeping their hands still for a few minutes, and some people may feel anxious about being in a clinic or talking about their condition during interviews. The software report is for research only and will not be used to guide participants care in this study.
Where is the study run from?
University of Manchester, UK.
When is the study starting and how long is it expected to run for?
December 2025 to June 2026.
Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.
Who is the main contact?
Sarah Wilkinson, sarah.wilkinson@manchester.ac.uk
Contact information
Public, Scientific
Salford Royal Hospital
C215 Clinical sciences building
Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
 ORCID ID |
0000-0002-8992-0801 |
|---|---|
| Phone | +44 (0)161 306 0544 |
| sarah.wilkinson@manchester.ac.uk |
Principal investigator
Division of Musculoskeletal and Dermatological Sciences School of Biological sciences
Oxford Road
Manchester
M13 9PL
United Kingdom
| ORCID ID |
0000-0003-4941-7926 |
|---|---|
| Phone | +44 (0)1612751634 |
| ariane.herrick@manchester.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Diagnostic | |
| Scientific title | Automated capillaroscopy evaluation in Raynaud's and SSc (ACERS): Supporting early diagnostic decision-making in the general rheumatology clinic | |
| Study acronym | ACERS | |
| Study objectives | The primary objectives of this study are: - to verify that the Capilytics nailfold capillaroscopy image acquisition and reporting system performs as expected under normal conditions of use; - to determine any undesirable side effects or risks under normal conditions of use; - to assess whether any side-effects or risks are serious when weighed against the intended benefits of the device. - Secondary objectives of this study are to collect questionnaire responses, conduct interviews (semi-structured and think-aloud) and focus groups with target users and patients to contribute to the refinement of the software; - to assess the usability of the software (target user feedback) and clinical reports. | |
| Ethics approval(s) |
Approved 16/10/2025, West of Scotland REC 4 (Research Ethics – Room 29 2 nd Floor Administration Building Gartnavel Royal Hospital 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; +44 0141 314 4485/0213; ggc.wosrec4@nhs.scot), ref: 25/WS/0142 | |
| Health condition(s) or problem(s) studied | Systemic sclerosis spectrum disorders | |
| Intervention | This clinical investigation is a prospective, multi-centre study evaluating the Capilytics AI-based system developed for nailfold capillaroscopy image acquisition and analysis. Following the consent process, participants will be asked to complete an anonymous equality, diversity and inclusion (EDI) questionnaire. We are collecting this data to ensure that, as Sponsor, we can further understand any specific barriers to research participation in our studies. With this additional information, we aim to address any potential issues to allow us to make our research as inclusive and wide-reaching as possible. This will not be stored with the research data and will not have any identifiable information included in the EDI questionnaire. Participants will then begin the image acquisition process. The investigator will ensure the equipment is set up ready for use. This includes: the study laptop (with the CapilyticsAcquisition software installed), Dino-Lite CapillaryScope, oil and pipette. The Dino-Lite CapillaryScope is a portable, handheld microscope that will be connected to the laptop provided to each participating site. Pre-session checks will be required prior to image acquisition (e.g., ensuring the Dino-Lite CapillaryScope is plugged in to the laptop). A small amount of oil will be placed along the nailfold of each finger prior to imaging to improve image quality. The imaging session will then begin. After a short calibration task, the software will guide the user to acquire nailfold capillaroscopy images from eight digits (thumbs excluded). The Dino-Lite CapillaryScope will be cleaned after each participant to minimise the risk of transmission of infection. After the examination, the participant will be asked to complete a short questionnaire about their experience of the procedure. The clinical team member performing the examination will be asked to complete a short questionnaire about their experience of the procedure after the first and last participant they image. This will include a set of 10 questions for assessing the usability of the system on the standardised System Usability Scale (SUS). Questionnaires will be made available to complete online using Qualtrics or using paper copies. Following the examination, a simple report including representative images from the examination will be provided to the rheumatologist. Based on this, and any other clinical information available, the clinician will be asked to provide their opinion of the degree of vessel abnormality present, and their patient management decision. Once this data has been collected, a full clinical report will be released, providing an abnormality score, based on the nailfold capillaroscopy images with reference to a normal range, and a grading on a clinically relevant four-point scale: 1. Normal 2. Probably normal 3. Probably abnormal 4. Definitely abnormal Other features of the report include: - An indicator of image quality - A report of capillary parameters (e.g. width and density) - Raw image data - Supporting data The report is intended to be for research use only and is not intended to be relied upon to make a diagnosis or to guide management of the patient. All clinical decisions should be made prior to receipt of the report. At the end of the study, all images collected and reports generated will be reviewed by a panel of capillaroscopy experts to establish a definitive categorisation of the degree of vessel abnormality and appropriateness of the report. If there is a discrepancy between the diagnosis and the clinical report, the report and capillaroscopy images will be reviewed immediately by the project clinical Chief Investigator and the clinical care team will be informed. The utility of reports, usability of the system, and alignment with clinical workflows will be investigated via validated questionnaires and semi-structured interviews with rheumatologists, patients and users. Patient participants, clinical users including SSc experts with experience of using the Capilytics system will be invited to take part in interviews and focus groups, to gather feedback on the usability, acceptability and impact of the system. Interviews and/or focus groups with the users of the device will happen in two stages; to explore the onboarding process and towards the end of recruitment to explore overall experiences of using the software. The onboarding interviews/focus groups will take place after at least two and no more than five participants. Users will be asked about their initial experiences of using the software, ease of use, for example "How easy or difficult was it to start using the software?", how helpful the training and inbuilt guidance was, how confident users were using the software with participants, and any suggestions they may have for improving the onboarding experience. Towards the end of the recruitment period and once users have had regular experience of using the software, they will be invited to take part in a second interview or focus group. This discussion will focus on the overall experience of using the software (from the image acquisition through to the utility of the clinical report). User's will be asked to reflect on how easy it was to use the software in a clinical setting, any challenges faced whilst using the software, how useful the clinical report was when making patient decisions, and suggestions for future improvement. Interviews and focus groups will be held face-to-face where possible, or remotely (via Microsoft Teams or Zoom), or by phone, depending upon the availability of the participants. Written informed consent will be sought from all participants prior to the focus groups or interviews, including consent to be audio recorded. To maintain anonymity all participants will be assigned a study number. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | CapilyticsAcquisition | |
| Primary outcome measure(s) |
The primary endpoints of this project are: | |
| Key secondary outcome measure(s) |
Secondary endpoints of this project are: | |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 6 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 375 |
| Key inclusion criteria | Patient participants: 1. 15 participants per site with established SSc (SSc)-spectrum disorders 2. Adults over 18 years 3. All should fulfil the 2013 ACR/EULAR classification criteria for SSc Children over 6 years and under 18 years of age (at Alder Hey only): 1. All should fulfil the 2013 ACR/EULAR classification criteria for SSc, OR have juvenile dermatomyositis (JDM) 2. Patients with overlap syndromes may be included, as long as they fulfil the criteria for either SSc or JDM. 1. 30 participants per site presenting with Raynaud’s phenomenon but no previous diagnosis of SSc. 2. Adults over 18 years 3. Patients who are referred for capillaroscopy with Raynaud’s phenomenon, and either a new referral or first seen (at the participating hospital) within the last 2 years Children over 6 years and under 18 years of age (at Alder Hey only): Referred primarily with Raynaud’s phenomenon and either a new referral or first seen (at Alder Hey) within the last 2 years Healthcare Professional participants (qualitative research aspect only): 1. Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology-trained professionals 2. Experience with the use of the Capilytics system during this study. |
| Key exclusion criteria | 1. 15 participants per site with established SSc (SSc)-spectrum disorders: 2. Any reason why nailfold capillaroscopy would be difficult, such as marked finger contractures or painful digital ulcers 3. Diabetes 4. Any disorder limiting the ability to provide informed consent or comply with the study requirements 30 participants per site presenting with Raynaud’s phenomenon but no previous diagnosis of SSc: 1. A defined connective tissue disease (including JDM), vasculitis or inflammatory arthritis (note patients with Very Early Diagnosis of SSc [VEDOSS] may be included, but not patients who fulfil the 2013 classification criteria for SSc or who score 7 or more points on the classification criteria without nailfold capillaroscopy, i.e. if nailfold capillaroscopy is abnormal, they would fulfil the criteria) 2. Presence of a known secondary cause for Raynaud’s phenomenon 3. Any reason why nailfold capillaroscopy would be difficult, e.g. finger deformities 4. Diabetes |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Stott Lane
Salford
M6 8HD
England
Eaton Road
West Derby
Liverpool
L12 2AP
England
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
England
Pond Street
London
NW3 2QG
England
Leicester
LE1 5WW
England
2 Eday Road
Aberdeen
AB15 6RE
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
14/11/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
