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Management of the Diabetic Foot Using Electrolysed Water

NCT02841969 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-22

No results posted yet for this study

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.

Conditions

  • Diabetic Foot

Interventions

OTHER

Electrolysed water

Irrigation of wound using electrolysed water

OTHER

Prontosan

Irrigation of wound using Prontosan

Sponsors & Collaborators

  • Aqualution Systems Ltd

    collaborator UNKNOWN

  • NHS Lanarkshire

    lead OTHER_GOV

Principal Investigators

  • Stephanie Dancer (MBBS, FRCP), MD · NHS Lanarkshire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841969 on ClinicalTrials.gov