SOLEFUL 1
Research type
Research Study
Full title
Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Pilot 3-Arm Randomised Control Trial and Qualitative Study (SOLEFUL)
IRAS ID
311664
Contact name
Louise Hitchman
Contact email
Sponsor organisation
Hull University Teaching Hospital NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Worktribe, 3660370; NIHR, 301807
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Diabetes foot ulcers affect 25% of people with diabetes and often fail to heal. This is associated with amputation and death. Extracorporeal shockwave therapy (high power soundwaves) is a non-invasive treatment that is delivered directly to the ulcer and may improve healing. However, the effectiveness of shockwave therapy and the optimum dose is unknown.
The aim of this study is to:
- Carry out a preliminary (pilot) trial comparing sham (not active) shockwave therapy, low number of shockwaves and high number of shockwaves on diabetes foot ulcers
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
The research has been co-designed by patients and their families with experience of diabetic foot ulcers.Pilot Trial:
Ninety patients who have a diabetic foot ulcer will be randomly assigned to one of the three treatment groups:
- High dose shockwave therapy
- Low dose shockwave therapy
- ‘Sham’ shockwave therapy
Each treatment will be delivered in a 3x30minute sessions over a 7 day period. All patients will receive usual ulcer care. Face to face follow up appointments will be at 6 weeks, 12 weeks and 24 weeks after study entry to measure ulcer healing, changes in quality of life and health resource use.Interviews:
Informal interviews, lasting around 30minutes, will be undertaken to explore patient opinion of shockwave therapy, experience of taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy. 24 patients and 8 clinicians will be invited to take part.REC name
Wales REC 4
REC reference
22/WA/0089
Date of REC Opinion
12 Apr 2022
REC opinion
Favourable Opinion