Co-designing DU opportunities
Research type
Research Study
Full title
Co-designing improvements in care and self-care opportunities for scleroderma digital ulcers with patients and clinicians
IRAS ID
320344
Contact name
Jackie Sturt
Contact email
Sponsor organisation
Kings College London
Clinicaltrials.gov Identifier
NCT05785403, ClinicalTrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Scleroderma is a rare crippling chronic disease associated with damage of the blood vessels and hardening of connective tissue. It has quite a number of complications including ulcers to the fingers and toes (digital ulcers). Digital ulcers (DU) are a frequent challenge in patients with scleroderma, as they approximately affect more than half of these patients. These ulcers are very painful, take a long time to heal, and are disabling. In most severe form, they lead to complications such as infection and amputations. These complications may result in hospital admissions, loss of work, ill-health, and reduced quality of life. Care received by patients with DU is varied. Those with three or more ulcers are considered to have severe disease therefore they usually receive expensive treatments and referred to specialist scleroderma clinics, while those with fewer ulcers may not receive the same treatments, and only see their general practitioner or local rheumatologist or are left to their own means. These patients develop their own DU managing practices which may be good and some not.
Currently, no research has fully identified the needs of patients with DU and opportunities to improve the ulcer care are lacking. We do not know the extent to which DU support needs are met by non-specialist healthcare professionals. Developing self-care opportunities and pathways for managing DU with patients and healthcare professionals will enhance DU care.
The aim of this research is to co-design self-care opportunities and improvements in care with patients suffering from DU and healthcare professionals. The objectives include; examining how patients are currently managed, identifying how patients currently manage their DU, what their unmet needs are and to co-design self-care opportunities and ways to improve DU care with patients and healthcare professionals.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0206
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion