Status:
NOT_YET_RECRUITING
SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
Lead Sponsor:
NHS Lanarkshire
Conditions:
Foot Ulcers, Diabetic
Foot Ulcer Unhealed
Eligibility:
All Genders
18-89 years
Phase:
NA
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...
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 organism...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06908148
Start Date
July 1 2025
End Date
September 1 2026
Last Update
April 3 2025
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