Health Sciences
Sharp debridement of digital ulcers in Systemic Sclerosis: a multi-centre randomised controlled feasibility study (SHED SSc)
Scleroderma (also called systemic sclerosis) is a complex connective tissue disease which causes the formation of painful ulcers on the fingers or toes, in around half of affected patients. These are medically known as digital ulcers (DUs). DUs take a long time to heal (76 days on average) and can lead to infections, pain, gangrene, hospitalisation and amputation. Appropriate treatment guidelines are needed to increase the recovery time, reduce the physical and emotional burden on patients and to reduce associated healthcare costs.
Clinical experience from two of the most experienced units for the management of DUs suggests that using sharp debridement, i.e. removing dead cells with a scalpel blade to prepare the wound bed for new skin cells, might reduce the healing time. As there is no solid evidence for its effectiveness at present, a well-designed randomised controlled trial is required to determine whether sharp debridement does allow DUs to heal quicker.
This study is a feasibility randomised control trial; therefore it aims to determine whether a full trial would be possible. Patients aged over 18 years with a positive diagnosis of Scleroderma and at least one active digital ulcer on the fingers or toes form two NHS clinics in England will be invited to participate. Those who consent to participate will be randomly assigned either standard wound care or standard wound care plus sharp debridement. The participants will be monitored over 24 weeks to provide treatment and assess whether their wound has healed. At 12 and 24 weeks after joining the trial, patients will be asked to complete a questionnaire. The rate of patient recruitment and the number of participants who continue with the study until the end will be monitored to see if a larger study would be achievable.
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Funding
| Funder(s): | Health Education England and National Institute for Health Research (NIHR) via Integrated Clinical Academic Programme (Clinical Lectureship) (ICA-CL-2018-04-ST2-015) |
|---|---|
| Start Date: | November 2021 |
| End Date: | March 2023 |
Members
YTU Team:
- Dr Jude Watson - Co-applicant
- Professor David Torgerson - Co-applicant
- Ms Caroline Fairhurst - Co-applicant
External Members:
- Dr Begonya Alcacer-Pitarch, Leeds Teaching Hospital NHS Trust and University of Leeds - Chief Investigator
- Professor Anthony Redmond, University of Leeds - Co-applicant
- Professor Andrea Nelson, Glasgow Caledonian University - Co-applicant
- Professor Christopher Denton, University College London and Royal Free Hospital, London - Co-applicant
- Professor Chris Bojke, University of Leeds - Co-applicant
- Dr Francesco Del Galdo, University of Leeds - Co-applicant
- Dr Philip Laws, Leeds Teaching Hospitals NHS Trusts - Co-applicant
- Julia Coakes - Patient and Public Involvement/Engagement representative
- Lynne Lister - Patient and Public Involvement/Engagement representative
