Clinical trial NCT06908148: SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
Official title: SALACIA: Randomised Control Trial of SALvesAn Neutral Electrolysed Water Versus Conventional Management of Non-healing dIAbetic Foot Wounds
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Foot Ulcers, Diabetic
Foot Ulcer Unhealed
Keywords: Foot Ulcers
Diabetic
Wound Healing
Electrolysed Water
Lead sponsor: NHS Lanarkshire
Sponsor class: OTHER_GOV
First posted: 2025-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial to compare electrolysed water against conventional management of non-healing diabetic foot wounds
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: 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
timeFrame: From enrollment to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aqualution
name: Michelle Lewis
role: STUDY_DIRECTOR
References: