Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Pilot 3-Arm Randomised Control Trial and Qualitative Study (SOLEFUL).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Eligibility ratio and recruitment ratio
研究概览
简要总结
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:
- 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
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
- 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:
- High dose shockwave treatment
- Low dose shockwave treatment
- "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
详细描述
There is an urgent need for better treatments for diabetic foot ulcers. Despite current best treatment, diabetic foot 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.
This research is going to look at a new therapy called Extracorporeal Shockwave Therapy. 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. We will investigate if shockwave therapy improves diabetic foot ulcer healing. To do this we will undertake a randomised controlled trial. The trial will randomly allocate people (who are eligible to take part and consent) into one of three groups: sham shockwave therapy, low dose shockwave therapy and high dose shockwave therapy. The patient will not know which group they are in. The researcher collecting wound data will not know which group the patient is in. This is to ensure we and the patient do not influence the results of the study. This is a rigorous way of comparing new treatments to existing ones.
The purpose of the pilot trial is to provide information to be able to repeat this trial again with a larger number of people. This pilot trial will help identify any problems and address any issues before the main trial starts. This minimises the risk of wasting money and people's time.
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Use of sham therapy for participant. Blinded outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sham shockwave therapy
Sham shockwave therapy in standard ulcer care.
干预措施: Extracorporeal Shockwave Therapy (Device)
Low dose shockwave therapy
100 shocks per cm2 plus standard ulcer care
干预措施: Extracorporeal Shockwave Therapy (Device)
High dose shockwave therapy
500 shocks per cm2 plus standard ulcer care
干预措施: Extracorporeal Shockwave Therapy (Device)
结局指标
主要结局
Eligibility ratio and recruitment ratio
时间窗: 19 months
Number eligible patients/number patients screened / recruited
Follow up rates
时间窗: 24 weeks
No. of participants who attended each follow-up appointments / no. of follow-up
Patient and clinician acceptability of the trial process and ESWT
时间窗: 24 weeks
Semi-structured in depth interviews
Adherence to treatment
时间窗: 19 months
Number participants who completed the treatment protocol/number participants in the trial.
Percentage of missing data at each follow up point
时间窗: 24 weeks
Number of missing data points over number of data points x100
次要结局
- Reduction in ulcer size at each study visit(24 weeks)
- Validity, reliability and responsiveness of WoundQol in patients with a DFU(24 weeks)
- Proportion of DFUs healed at 6 months(24 weeks)
- Adverse events(24 weeks)
- Time to DFU healing(24 weeks)
- Cost differences between ESWT and standard care alone(24 weeks)
- Validity, reliability and responsiveness of virtual follow-up for wound healing in research(24 weeks)
- Quality of life questionnaires(24 weeks)