SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorNHS Lanarkshire
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Electrolysed water
DeviceElectrolysed 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.
Conventional irrigant
DeviceThe irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Electrolysed waterExperimental treatment 1 intervention
Group B: Conventional irrigantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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.
Time frame
From enrollment to 20 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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