NCT02841969: NEWfeet

Management of the Diabetic Foot Using Electrolysed Water

Suspended NA Last updated 22 April 2022

What this trial tests

NA trial testing Electrolysed water in Diabetic Foot in 200 participants. Suspended.

Timeline

28 February 2017

Primary endpoint
30 September 2023

31 December 2023

Quick facts

Lead sponsor	NHS Lanarkshire
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	28 February 2017
Primary completion	30 September 2023
Estimated completion	31 December 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Electrolysed water
• Prontosan — full drug profile →

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

NHS Lanarkshire

Who can join

Adults 18 to 65, any sex, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.