Management of the diabetic foot using electrolysed water (E-Water)
Research type
Research Study
Full title
Randomised double blind controlled trial of Neutral Electrolysed Water vs conventional management of non-healing diabetic feet (E-Water study)
IRAS ID
186504
Contact name
Stephanie Dancer
Contact email
Sponsor organisation
Aqualution Systems Ltd. (Scotland)
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
More patients with diabetes mellitus have led to increasing rates of chronic non-healing 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 with electrolysed water reduces bacterial load and appears to encourage wound healing. Following an encouraging pilot study, we propose to compare electrolysed water against conventional management for diabetic patients with non-healing foot ulcers. Adult diabetics with chronic ulcers attending podiatry at Hairmyres Hospital will be recruited to receive regular debridement and irrigation of wounds using either in-use product (Prontosan™) or electrolysed water as part of a prospective randomised controlled trial. Strict enrolment criteria will be applied, with regular clinical assessment and microbiological screening. Lesions present for >6 weeks and >2cm will be photographed at trial entry and graded using standardised criteria. Wounds will be monitored for at least 12 weeks (max. 20), with primary composite end-point defined as complete healing; >50% healing of initial lesion; and/or avoidance of surgical intervention. Secondary endpoints are surgical intervention, including debridement or amputation; antibiotic therapy; and/or patient death. The main objective is to compare rapidity of wound healing using either in-use product or electrolysed water. Improved healing could potentially benefit patients who might otherwise progress to amputation. We will also monitor antimicrobial consumption in study patients throughout the trial. A final objective is to cost the use of electrolysed water vs cost of Prontosan in the routine management of diabetic foot ulcers.
REC name
West of Scotland REC 3
REC reference
16/WS/0235
Date of REC Opinion
31 Jan 2017
REC opinion
Further Information Favourable Opinion