SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds

NCT ID: NCT06908148

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-09-01

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.

Conditions

Foot Ulcers, Diabetic; Foot Ulcer Unhealed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrolysed water

Intervention Type: DEVICE

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.

Conventional irrigant

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

Group Type: ACTIVE_COMPARATOR

Conventional irrigant

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Conventional irrigant

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lanarkshire

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Lewis

Role: STUDY_DIRECTOR

Aqualution

Central Contacts

Michelle Lewis

Role: CONTACT

michelle.lewis@aqualution.co.uk

+44(0)1361 883575

Stephanie Dancer, MD

Role: CONTACT

stephanie.dancer@lanarkshire.scot.nhs.uk

+44(0) 1355585000

Other Identifiers

L22044C

Identifier Type: -

Identifier Source: org_study_id