SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrolysed water, Conventional irrigant.
- Who it may be relevant to
- Registry conditions: Foot Ulcers, Diabetic, Foot Ulcer Unhealed. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SALACIA: Randomised Control Trial of SALvesAn Neutral Electrolysed Water Versus Conventional Management of Non-healing dIAbetic Foot Wounds
Overview
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.
Detailed description
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.
Primary objective is to compare rapidity of wound healing. Secondary endpoints are surgical intervention, debridement, amputation, patient death.
Improved healing could potentially benefit patients who might otherwise progress to amputation. The investigators will monitor antimicrobial consumption in study patients throughout the trial. A final objective is to carry out an economic evaluation of electrolysed water vs Prontosan in the routine management of non-healing foot ulcers.
Interventions
- Device Electrolysed water
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. We propose to compare electrolysed water against conventional management. - Device Conventional irrigant
The irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds
Primary outcome measures
- 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 [Time frame: From enrollment to 20 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06908148 · L22044C