Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

Summary of the problem: Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life. Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown. The aim of the study: 1. To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing 2. To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians 3. To investigate the cost effectiveness (value for money) of shockwave therapy Methods 1\. Pilot Trial: Ninety patients with DFU will be randomly assigned to one of three treatment groups: 1. High dose shockwave treatment 2. Low dose shockwave treatment 3. "Sham" shockwave treatment Each treatment will be delivered in 3x30minute sessions in a 7-day period. Face-to-face follow up appointments will take place 1, 2, 3 and 6 months after treatment to measure ulcer healing and changes in quality-of-life. Interviews Interviews to explore patient opinion of shockwave therapy, experience in taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy

Inclusion Criteria: * At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks * Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25) * Capacity to consent to participate in the trial and given written informed consent * Willing to be randomised to either sham, low-dose or high-dose ESWT * Willing to consent to photography of the index DFU * Willing to comply with the follow up schedule Exclusion Criteria: * Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits. * Currently on or planned treatment for osteomyelitis. * Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT. * Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT. * All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT. * Active participants in other trials that may conflict with the study outcomes, for example any other wound care trials.