NCT06291142Completed
Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot
NIHR i4i 2: Early Diagnosis of Systemic Sclerosis in the General Rheumatology Clinic - Pilot Image Acquisition Study
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 112 (actual)
- First submitted
- 26 Feb 2024
- Start date
- 22 Nov 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Manchester
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06291142
What you commit to
- Study type: Observational
- Participants enrolled: 112
- From 22 Nov 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (Healthy controls). Requirement for vasoactive therapies
Other illness
- (Patients; image acquisition and skin tone study). Diabetes
- (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.
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northern Care Alliance NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.