100 DU STUDY
Research type
Research Study
Full title
Optimising the assessment and novel mechanistic insights into digital ulcers in systemic sclerosis: Validation of the preliminary Systemic Sclerosis impact of Digital Ulceration (SSiDU) questionnaire
IRAS ID
359781
Contact name
Michael Hughes
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
47721, ISRCTN Registry
Duration of Study in the UK
1 years, 3 months, 17 days
Research summary
Digital ulcers (DU) remain a major cause of disease-related morbidity in systemic sclerosis (SSc). Previous clinical trials of SSc-DU have previously focussed primarily on clinician assessment of DU occurrence and healing which has led to a "knowledge gap". The relative efficacy of current approaches to DU management have led to a reduction in the frequency of new DU, which has significantly hampered traditional clinical trial design in this field. Nonetheless, SSc-DU remain a major problem for patients and the success of future clinical trials to further optimise the assessment and optimal management of SSc-DU will be dependent on important unmet research needs first being addressed. One vital unmet need concerns the assessment of DU symptom severity and impact during DU healing. As the focus of future trials shifts from new DU prevention to assessing therapeutic interventions that can promote and accelerate wound healing, we require outcome measures that can capture this. Previous trials have placed comparatively little emphasis how patients ‘feel’ and ‘function’ (central to FDA drug approval). To date, the lived experience of SSc-DU has largely been captured using legacy patient-reported outcome (PRO) instruments, which do not capture important experiences specific to SSc-DU such as emotional distress and social participation.
The present study shall enable us to further elaborate and validate the Systemic Sclerosis Impact of Digital Ulcer (SSiDU) questionnaire for assessing the severity and impact of SSc-DU for use in future observational studies and clinical trials. The domains of the ‘SSiDU’ questionnaire are grounded in the patient experience of SSc-DU, derived from recent SCTC-supported multicentre qualitative research.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0184
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion