The international ‘100 DU’ study
This study, called ‘100 DU’, is an international project looking into digital ulcers (sore spots on fingers and toes) in people with systemic sclerosis. More than half of people with systemic sclerosis develop these ulcers, which can be very painful and make everyday tasks difficult. The study aims to create a new, easy-to-understand questionnaire. This questionnaire will help doctors and researchers properly understand how these ulcers affect patients' feelings and daily activities. Up until now, most studies have focused on how often these ulcers appear and how they heal, rather than the patient's own experience. This new tool will help improve treatment and support for people with this condition. The study will also explore why some ulcers develop differently in various patients.
At a glance
What is this study about?
This research is focused on a condition called systemic sclerosis, which is a rare, long-term illness. A common problem for people with systemic sclerosis is getting sore spots, called digital ulcers, on their fingers and toes. These ulcers can cause a lot of pain and make it hard to do normal daily activities, significantly affecting their quality of life.
While doctors have studied how often these ulcers appear and how they heal, there hasn't been enough focus on how people actually *feel* and *function* with these ulcers. This study aims to change that. Researchers want to create a new questionnaire that specifically asks about the patient's experience. This tool will help better understand how digital ulcers impact everyday life, beyond just their physical appearance.
By gathering information from 100 patients, the researchers hope to make this new questionnaire a reliable way to measure the pain and challenges caused by digital ulcers. This will help doctors and researchers develop better ways to assess and potentially treat this condition in the future. The study will also look at different types of ulcers and what might cause them, to connect this information to how patients experience them.
Key takeaways
- The study aims to improve understanding of how digital ulcers affect daily life.
- It will develop a new patient questionnaire to better capture feelings and function.
- Participation involves completing online questionnaires; no new treatments are given.
- The study runs from July 2025 to December 2026.
- It is for people with systemic sclerosis who currently have digital ulcers.
- There are no additional medical risks or benefits expected from taking part.
Who may be eligible?
This study is looking for volunteers who have systemic sclerosis and currently have an active digital ulcer. You must be 18 years or older to take part.
To join, you'll need to be able to fully understand the study requirements and agree to participate by giving written consent. It's also important that you have a good understanding of spoken and written English, as the questionnaires are in English.
Unfortunately, you cannot take part if you are pregnant, or if you've recently changed your medication for blood vessel problems (within the last two weeks before the study starts).
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.
- Do you have systemic sclerosis?
- Do you currently have an active sore (digital ulcer) on your finger or toe?
- Are you 18 years old or older?
- Can you understand written and spoken English well?
- Are you able and willing to complete questionnaires online?
- Are you NOT pregnant and have you NOT changed your blood vessel medication in the last 2 weeks?
What does participation involve?
If you decide to take part in this study, you will be asked to complete several questionnaires. These questionnaires will be filled in by you, using a secure online system from your computer or device. Your doctors will also provide some information about your health using a special form. The study will run from July 2025 to December 2026. This study does not involve new medications or extra doctor's appointments; it's focused on gathering information about your current experience.
Potential risks and benefits
Locations (14)
- North Bristol NHS TrustCity onlyBristol, England
- University College London Hospitals NHS Foundation TrustCity onlyLondon, England
- University of LeedsApproximateLeeds, England
- Northern Care Alliance NHS Foundation TrustCity onlySalford, England
- Liverpool University Hospitals NHS Foundation TrustCity onlyLiverpool, England
- The Dudley Group NHS Foundation TrustUnverifiedDudley, England
- Hospital for Special SurgeryUnverifiedUnited States of America
- Johns Hopkins UniversityUnverifiedUnited States of America
- University of MichiganUnverifiedUnited States of America
- New Orleans Scleroderma and Sarcoidosis Patient Care and Research CenterUnverifiedUnited States of America
- Vanderbilt University Medical CenterUnverifiedUnited States of America
- Yale UniversityUnverifiedUnited States of America
Common questions
What are 'digital ulcers'?
Digital ulcers are sore spots or wounds that appear on the fingers or toes, often painful and making it difficult to use your hands or feet.
What is 'systemic sclerosis'?
Systemic sclerosis is a rare long-term condition that affects the skin, blood vessels, and internal organs, and can cause these finger and toe sores.
What is a 'PRO instrument'?
A PRO instrument is a special questionnaire or survey that helps doctors understand an illness from the patient's point of view, asking about their symptoms and how they feel.
Will I have to take new medication?
No, this study does not involve taking any new medications. You will continue with your existing medical care as usual.
Who is paying for this study?
The study is being funded by two organisations: the Scleroderma Clinical Trials Consortium (SCTC) and the Scleroderma Research Foundation (SRF).
How to find out more
Michael Hughes
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.