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
Qualifiers
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
Treatments tested in this trial
- Electrolysed water
- Conventional irrigant
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov