RecruitingNot ApplicableInterventional

A multi-centre study testing a new imaging app to help diagnose systemic sclerosis using nailfold capillaroscopy

This study is testing a new software system, CapilyticsAcquisition, which helps healthcare professionals take and analyse images of tiny blood vessels near the fingernails. This process, called nailfold capillaroscopy, is important for assessing conditions like Raynaud’s phenomenon and systemic sclerosis (SSc). The goal is to make it easier for general clinics to use this technology, helping doctors diagnose these conditions earlier and more accurately. Participants aged 6 and over who are being checked for Raynaud's or SSc will have their fingernails imaged, complete questionnaires, and provide feedback on the system. The study aims to refine the software before it can be widely used, ultimately improving care for future patients.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Manchester

Enrolment target

375

Start

22 Dec 2025

Estimated completion

30 Jun 2026

Systemic sclerosis spectrum disorders

What is this study about?

This research study is looking into a new computer program called CapilyticsAcquisition. Think of it like a smart app designed to help doctors get a better look at and understand the tiny blood vessels at the base of your fingernails. This technique, called nailfold capillaroscopy, is really important because changes in these tiny vessels can be a sign of certain health conditions, particularly Raynaud's phenomenon and systemic sclerosis (SSc).

The main idea behind CapilyticsAcquisition is to make it simpler for doctors and nurses in regular clinics to use this special imaging. It guides them to take good quality photos and then automatically creates a report. This report is hoped to give doctors clearer information, which could lead to earlier and more accurate diagnoses for people with these conditions. The study wants to make sure the system works well, is easy to use, and helps doctors make better decisions about care.

By taking part, you'd be helping to test this new technology. While the information from this software won't change your personal treatment during the study, your input is incredibly valuable. It will help researchers improve the system so that it can eventually benefit many other patients in the future, making it easier for hospitals across the UK to offer this helpful diagnostic tool.

Key takeaways

This study is piloting a new digital tool for diagnosing conditions like systemic sclerosis.
It involves taking pictures of tiny blood vessels in your fingernails.
Participation could help improve future diagnosis for others, but won't change your current care.
The imaging process is very low risk and suitable for adults and children aged 6+.
Your feedback is important for making the new system better.
The study runs from December 2025 to June 2026 and is funded by the NIHR.

Who may be eligible?

You might be able to take part if you are an adult or a child aged 6 or older and are currently being assessed for Raynaud's syndrome or systemic sclerosis (SSc). Specifically, this includes adults who have been diagnosed with SSc or are experiencing Raynaud's phenomenon for the first time or within the last two years.

Children aged 6 and over being seen at Alder Hey Children's Hospital with SSc, juvenile dermatomyositis (JDM), or who have Raynaud's phenomenon, may also be able to join. Your doctors will check if you meet all the research criteria for your specific condition.

You might not be able to take part if you have certain other health conditions like diabetes, or if it would be difficult to take clear pictures of your fingernails due to severe finger problems. There are also specific reasons related to other types of illnesses that might mean you're not suitable for this study; your doctor will be able to discuss these with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 6 years old or older?
Are you currently being assessed for Raynaud's phenomenon?
Have you been diagnosed with systemic sclerosis (SSc)?
Are you able to keep your hands still for a few minutes?
Do you have any other conditions like diabetes?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is to read and understand all the study information, and then give your permission (consent). You'll then fill out a short questionnaire about your health.

The main part involves having pictures taken of the tiny blood vessels at the base of your fingernails using the new CapilyticsAcquisition system. This can happen during one of your regular clinic visits or at a special study appointment. After the pictures are taken, they will be securely sent to The University of Manchester for analysis. The system will then create a report.

Your doctor will review some of your images and give their own opinion before seeing the automatic report. Afterwards, they will look at the full report and tell the researchers what they think of it. Both you and your doctor will also be asked to complete questionnaires about your experience. Some participants and all healthcare professionals involved may also be invited for interviews or group chats to help make the system even better. The total time you spend actively involved in the study will depend on whether you are asked for an interview, but the imaging session itself is generally quite quick.

Potential risks and benefits

Participating in this study has potential benefits, as your involvement could help improve how conditions like Raynaud's and SSc are diagnosed in the future. By testing this new system, you're contributing to making diagnosis potentially quicker and more accurate for others. Though the report from the software won't directly guide your treatment during this study, your contribution is vital for developing technology that could improve future care. The risks are very low; the procedure only involves taking pictures of your fingernails, which might cause mild discomfort if you have to keep your hand still for a few minutes. Some people might feel a little anxious in a clinic setting or when talking about their health, which is normal. Remember, you can choose to stop taking part in the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Northern Care Alliance NHS Foundation Trust
City only
Salford, England
Alder Hey Children's NHS Foundation Trust Laboratory
City only
Liverpool, England
Stepping Hill Hospital
Approximate
Stockport, England
Royal Free London NHS Foundation Trust
City only
London, England
Leicester Royal Infirmary
Approximate
Leicester, England
NHS Grampian
Unverified
Aberdeen, Scotland

Common questions

What is systemic sclerosis?

Systemic sclerosis (SSc) is a rare, long-term condition that mainly affects the skin and internal organs, caused by the immune system mistakenly attacking healthy tissue. Raynaud's phenomenon often happens first, causing fingers and toes to change colour in cold or stress.

What is nailfold capillaroscopy?

It's a simple, non-invasive test where doctors examine the tiny blood vessels (capillaries) at the base of your fingernails using a special microscope. These vessels can show early signs of certain conditions like systemic sclerosis.

Will the CapilyticsAcquisition system diagnose me?

During this study, the report from the CapilyticsAcquisition system is for research purposes only and will not be used to make decisions about your care or diagnosis right now. Your doctor will make diagnoses and treatment plans based on their usual assessments.

How long will my visit take?

The imaging session for your fingernails is usually quite quick. You'll also complete a short questionnaire. If you're invited for an interview or group discussion, that will be a separate, longer session.

Who is paying for this research?

This study is funded by the National Institute for Health and Care Research (NIHR) in the UK, which supports important health and social care research.

How to find out more

Sarah Wilkinson

sarah.wilkinson@manchester.ac.uk +44 (0)161 306 0544 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.