Foot Ulcers, DiabeticSALACIANCT06908148
SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
A study testing Electrolysed water and Conventional irrigant in people with Foot Ulcers, Diabetic and Foot Ulcer Unhealed, run by NHS Lanarkshire.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Foot Ulcers, Diabetic, Foot Ulcer Unhealed
- What is being tested?
- Electrolysed water and Conventional irrigant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SALACIA: Randomised Control Trial of SALvesAn Neutral Electrolysed Water Versus Conventional Management of Non-healing dIAbetic Foot Wounds
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.
Read the 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
- Being tested
- Electrolysed water, Conventional irrigant
- Keywords
- Foot Ulcers, Diabetic, Wound Healing, Electrolysed Water
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolysed waterDevice
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 irrigantDevice
The irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electrolysed water |
| Conventional irrigant | Active comparator | The irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds Receives: Device: Conventional irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcers, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial to compare electrolysed water against conventional management of non-healing diabetic foot wounds
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Lanarkshire
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michelle Lewis, Study director, Aqualution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908148
- Sponsor's protocol ID
- L22044C
- Acronym
- SALACIA
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALACIA: Randomised Control Trial of SALvesAn Neutral Electrolysed Water Versus Conventional Management of Non-healing dIAbetic Foot Wounds
- ClinicalTrials.gov ID
- NCT06908148
- Acronym / sponsor ID
- SALACIA / L22044C
- Conditions
- Foot Ulcers, Diabetic, Foot Ulcer Unhealed
- Keywords
- Foot Ulcers, Diabetic, Wound Healing, Electrolysed Water
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS LanarkshireOther government
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial to compare electrolysed water against conventional management of non-healing diabetic foot wounds
| Arm | Type | Receives |
|---|---|---|
| Electrolysed water | Experimental | Device: Electrolysed waterElectrolysed 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 | Active comparator | Device: Conventional irrigantThe irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrolysed waterElectrolysed 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 irrigantThe irrigant (Prontosan™) that is currently 'in-use' in the conventional management of diabetic foot wounds | Device | Conventional irrigant |
Primary outcome
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
Time frame: From enrollment to 20 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Lewis study director
Aqualution
Questions about this trial
What is this clinical trial studying?
A study testing Electrolysed water and Conventional irrigant in people with Foot Ulcers, Diabetic and Foot Ulcer Unhealed, run by NHS Lanarkshire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lewis (+44(0)1361 883575, michelle.lewis@aqualution.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From enrollment to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.