COLLAGE, version 1.2
Research type
Research Study
Full title
HyFaCol for scleroderma patients with digital ulcers
IRAS ID
240072
Contact name
Francesco Del Galdo
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
The aetiology of digital ulcers is multifactorial. It is a disease-related complication affecting approximately 50% of patients diagnosed with systemic sclerosis, and 20% of patients with connective tissue diseases. Studies in the past five years consistently report the debilitating impact of digital ulcers on hand function and quality of life. In particular, patients with digital ulcers struggle with simple tasks such as getting dressed and tying shoe laces. Digital ulcerations have been referred to as a significant ‘burden of disease’, which requires timely and effective treatment. Furthermore, open ulcers are prone to infections. Prevention of onset of infections warrants meticulous, swift and effective wound care. The average length of time for a digital ulcer to heal varies enormously, ranging between 4 to 108 weeks, according to the type of ulcers. Wound care for digital ulcers in scleroderma is complicated as wound healing is compromised by vascular damage and skin fibrosis. Time-to-heal can be augmented by an appropriate wound dressing. During this period, patients come to clinic fortnightly or monthly, depending on status of ulcer, for wound care. This study proposes the use of HyFaCol, a collagen hydrogel, developed in the University of Leeds, as wound dressing on digital ulcers in patients with scleroderma. The primary objective of this study is to examine the feasibility, safety and acceptability of application of HyFaCol dressing on patients with digital ulcers. HyFaCol is a collagen based dressing which had been tested on wounds in diabetic mice. It showed accelerated wound healing in a full thickness wound model. To date, no commercial dressing product with similar characteristics to HyFaCol is present in the market.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0396
Date of REC Opinion
25 Nov 2019
REC opinion
Favourable Opinion