Assessment of Botulinum Toxin A in the treatment of Raynaud’s Disease
Research type
Research Study
Full title
Objective Assessment of Botulinum Toxin A in the treatment of Raynaud’s phenomenon secondary to Scleroderma; a pilot study (student study)
IRAS ID
226094
Contact name
Peter Butler
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2017/10/64, UCL Data Protection Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Raynaud’s phenomenon (RP) is a vascular disorder of the digital vessels triggered by exposure to cold or stress. It is most commonly observed in the hands, but also affects the toes, nose and ears. Patients experience pain, problems with sensation, ulceration and possible amputation. It is common, affecting up to 19 % of the general population in the UK and is 9 times more likely in women than men. Depending on the severity it can have a significant impact on a patient’s daily activities. RP is either classified as primary or secondary. Primary RP or Raynaud's disease is unknown. Secondary RP, or Raynaud’s syndrome has several causes. Scleroderma is the most common cause, with RP occurring in 90% of patients. Secondary RP presents with more severe disease and are more likely to have associated complications. Botulinum toxin A (Btx-A), injected into the hands and toes, has been shown to be effective in the treatment of severe RP. However, no one has objectively assessed the outcome in secondary RP.
In this study, we will use a variety of non-invasive techniques including photography to objectively assess the improvement of hand function and improvement in symptoms, in response to Btx-A in 30 patients with secondary RP. The patients outcomes will be assessed using photography and patient outcome questionnaires. Professor Butler will identify participants in preoperative clinic at the Royal Free Hospital, prior to their fat treatment that are suitable for the study. Dr Griffin will gain written consent on the day of their operation to enter the study.
The information gained from this study will improve our knowledge of the efficacy of Btx-A treatment for Raynauds disease, allowing us to improve our surgical techniques and provide better outcomes for patients requiring these types of surgeries.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0218
Date of REC Opinion
13 Apr 2018
REC opinion
Further Information Favourable Opinion