Management of the Diabetic Foot Using Electrolysed Water

NCT02841969 | Suspended

• 2 other identifiers: NEWfeet_01L16077
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ulcer; Electrolysed; Water

Outcome Measures

Primary Outcomes (1)

• Rate of complete wound healing

  Compare the use of neutral electrolysed water in the management of chronic diabetic foot ulcers against routine NHS management, which uses Prontosan for antiseptic irrigation.

  12 weeks

Study Arms (2)

Normal care - Prontosan

ACTIVE COMPARATOR

Patient wounds will be irrigated using the in-use product (Prontosan)

Other: Prontosan

Investigational arm - Electrolysed water

EXPERIMENTAL

Patient wounds will be irrigated using electrolysed water

Other: Electrolysed water

Interventions

Electrolysed water OTHER

Irrigation of wound using electrolysed water

Also known as: Aqualution Salvesan

Investigational arm - Electrolysed water

Prontosan OTHER

Irrigation of wound using Prontosan

Normal care - Prontosan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult diabetic patients (18-65 years) with chronic (\>6 weeks) non-healing wounds(\>2cm2) identified and counselled by study clinicians, along with additional information supplied by the Patient Information leaflet.

You may not qualify if:

• Patients with underlying terminal disease will be excluded from this trial along with those with severe co-morbidities, 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. Patients with ongoing infection at trial entry will be treated and then reassessed. Any previous documented allergy to either Prontosan™ or electrolysed water will also exclude the patient. Any adverse effects thought to be due to either irrigant will necessitate study withdrawal and investigation. If there is doubt over the continuation of the correctly assigned irrigant for a specific patient, then that patient's data will be labelled as such and noted for the final analysis. This will also be the case and/or if there are lapses of more than 4 treatment sessions during therapy.

Sponsors & Collaborators

• NHS Lanarkshire: lead
• Aqualution Systems Ltd: collaborator

Study Sites (1)

Hairmyres Hospital

East Kilbride, Lanarkshire, G75 8RG, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Interventions

superoxidized water

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie Dancer (MBBS, FRCP), MD

  NHS Lanarkshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: February 28, 2017
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)