SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds

NHS Lanarkshire

Status: Not yet enrolling

Conditions: Foot Ulcers, Diabetic; Foot Ulcer Unhealed

Treatments: Device: Electrolysed water; Device: Conventional irrigant

Study type: Interventional

Funder types: Other

Identifiers

NCT06908148

L22044C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Electrolysed water

Experimental group

Description:

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.

Treatment:

Device: Electrolysed water

Conventional irrigant

Active Comparator group

Description:

The irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds

Treatment:

Device: Conventional irrigant