SHED SSc

• Research type

  Research Study

• Full title

  SHED SSc - SHarp dEbridement of Digital ulcers in Systemic Sclerosis: a multi-centre Randomised Controlled Trial feasibility study

• IRAS ID

  272506

• Contact name

  Begonya Alcacer-Pitarch

• Contact email

  b.alcacer-pitarch@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  1 years, 4 months, 31 days

• Research summary

  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. As intended for the full study, patients 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. If the study is a success, the full study will commence (using the opinions of medical staff and patients to adapt the protocol if required). If not, a full trial will not be pursued.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  21/YH/0278

• Date of REC Opinion

  23 Nov 2021

• REC opinion

  Favourable Opinion