SALACIA: Randomised Control Trial of SALvesAn Neutral Electrolysed Water Versus Conventional Management of Non-healing dIAbetic Foot Wounds
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Proportion of diabetic foot ulcers (wounds) that heal when irrigated using electrolysed water versus the proportion that heal when using the standard-of-care irrigant
研究概览
简要总结
Increasing prevalence of diabetes mellitus has led to increasing numbers of chronic non-healing foot ulcers (wounds).
Electrolysed water is a novel antiseptic which reduces bacterial load and appears to encourage wound healing. The investigators propose to compare electrolysed water against conventional management.
详细描述
Increasing prevalence of diabetes mellitus has led to increasing numbers of chronic non-healing foot ulcers (wounds). These wounds are colonised with pathogens, including multi-drug resistant organisms. Despite repeated courses of antibiotics, subsequent management is difficult due to devascularisation of surrounding tissues and healing failures. Ultimately, patients may require amputation.
Electrolysed water is a novel antiseptic produced by passing an electric current through a mixture of tap water and salt. Microbiocidal activity is due to the presence of hypochlorous acid at neutral Ph. Irrigation of chronic wounds reduces bacterial load and appears to encourage wound healing. The investigators propose to compare electrolysed water against conventional management.
Patients who attend NHS podiatry clinics, and who enrol in the trial, will receive treatment of their wounds as-per routine care; the only difference is the irrigant used. Patients will be randomised to use either the in-use product (Prontosan™) or electrolysed water (Salvesan).
The inclusion criteria are:
- Adult diabetic patients (18-89 years)
- Chronic wounds (present for >=3 weeks since commencing Podiatry care)
- Non-healing (wounds that, in the view of the patient's Podiatrist, are not responding to standard treatment)
- Wounds that are >=5mm when measured in any direction The treatment phase will last for 12 weeks (or less, if complete healing achieved). All patients will be followed up at 20 weeks to assess recurrence. Primary composite end-point defined as time to complete healing or proportion achieving >50% healing if complete healing is not achieved.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult diabetic patients (18-89 years)
- •Chronic wounds (present for >=3 weeks since commencing Podiatry care)
- •Non-healing (wounds that, in the view of the patient's Podiatrist, are not responding to standard treatment)
- •Wounds that are >=5mm when measured in any direction
排除标准
- •Patients lacking capacity to provide informed consent
- •Patients with underlying terminal disease
- •Patients with severe comorbidities, e.g. morbidly obese; uncontrolled diabetes (HbA1c > 97 mmol/mol); gangrene; chronic leg oedema/venous disease; end-stage renal disease; untreatable ischaemic heart disease; HIV; etc.
- •Women who are pregnant or breastfeeding will be excluded from this trial.
- •Women of child-bearing potential who are not using an acceptable form of contraception will be excluded from this trial.
结局指标
主要结局
Proportion of diabetic foot ulcers (wounds) that heal when irrigated using electrolysed water versus the proportion that heal when using the standard-of-care irrigant
时间窗: From enrollment to 20 weeks
This investigation seeks to determine whether irrigation of non-healing diabetic foot ulcers (wounds) using neutral electrolysed water (Salvesan) results in equivalent, or better, wound healing than the standard-of-care wound management irrigant (Prontosan® Solution). The primary outcome measure is the condition of the wound at the end of the study, with composite end-points defined as: (A) - for wounds that heal completely within the 12-week follow up period, the associated time to completely heal (B) - for wounds that do not completely heal, the number with \>50% healing of initial lesion at 12 weeks (defined as surface area in mm2 as measured using the standard methodology used within the Diabetic Podiatry service). The proportions of wounds that heal \[(A)- completely / (B) - with \>50% healing\] using each irrigant will be compared statistically to assess whether there is any difference in the proportion healed using electrolysed water versus standard-of-care irrigant.
次要结局
未报告次要终点