SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds

NCT06908148 | Not Yet Recruiting

• 1 other identifier: L22044C
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Foot Ulcers, Diabetic; Foot Ulcer Unhealed

Keywords

Foot Ulcers; Diabetic; Wound Healing; Electrolysed Water

Outcome Measures

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.

  From enrollment to 20 weeks

Study Arms (2)

Electrolysed water

EXPERIMENTAL

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.

Device: Electrolysed water

Conventional irrigant

ACTIVE COMPARATOR

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

Device: Conventional irrigant

Interventions

Electrolysed water 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.

Electrolysed water

Conventional irrigant DEVICE

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

Conventional irrigant

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lanarkshire: lead

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Michelle Lewis

  Aqualution

  STUDY DIRECTOR

Central Study Contacts

Michelle Lewis

CONTACT

+44(0)1361 883575; michelle.lewis@aqualution.co.uk

Stephanie Dancer, MD

CONTACT

+44(0) 1355585000; stephanie.dancer@lanarkshire.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised control trial to compare electrolysed water against conventional management of non-healing diabetic foot wounds

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: April 3, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-01