- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841969
Management of the Diabetic Foot Using Electrolysed Water (NEWfeet)
Randomised Double Blind Controlled Trial of Neutral Electrolysed Water vs Conventional Management of Non-healing Diabetic Feet (NEWfeet)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: The entrance criteria specify adult diabetic patients (18-65 years) with chronic (>6 weeks) non-healing wounds(>2cm2) identified by study clinicians and counselled by aid of a Participant Information sheet (PIS). Having considered the PIS for >24hrs, patients who wish to participate will provide signed formal consent and will be entered into the trial. Relevant demographic and clinical data will be recorded with baseline microbiology, blood tests and classification of wound and pain score. Wounds will be graded according to the Texas classification and photographed. Pain score at entry will be measured by modified McGill questionnaire and graded from 0(no pain) to 5(severe pain). Study patients will be randomly assigned to receive either in-use product or electrolysed water according to predetermined statistical protocol and will be given a code for continued identification. The patient's notes will be tagged with study and code information, with copies sent to the patient's GP.
The wound will be inspected, debrided, cleaned and irrigated twice a week using electrolysed water or in-use product (Prontosan™). In-patients may receive more frequent application (e.g. daily) depending upon wound status. This will be performed by ward nurses for in-patients and for outpatients by podiatrists in the Diabetic clinic. Patients will be assessed by podiatrists weekly (<=20wks) or until an agreed end-point is reached; research assessments will coincide with routine outpatient clinic attendance or in-patient review to minimise patient inconvenience.
Release of electrolysed water will be coordinated by the research scientist. Supplies will be decanted into identical containers in order to blind staff as to product identity. The bottles will be labelled 'A' or 'B. Patients randomised to receive study or in-use irrigant will continue with the same product, to which they were initially assigned.
If a patient develops an infection, then they will receive clinical review and microbiological screening. These patients will continue with trial irrigants but will be offered appropriate antibiotics according to laboratory data. They will be encouraged to complete the trial but their data will be analysed separately on final analysis.
Patients with underlying terminal disease will be excluded from this trial along with patients 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 necessitate exclusion. Any adverse effects thought to be due to either irrigant will prompt 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. All data will be retained for the final project report.
The primary composite end-points are: complete healing; >50% healing of initial lesion; and/or avoidance of surgical intervention including amputation. Secondary endpoints are: surgical debridement including amputation; antibiotic consumption; and patient death. Each patient lesion will be photographed at the agreed end-point.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lanarkshire
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East Kilbride, Lanarkshire, United Kingdom, G75 8RG
- Hairmyres Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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Exclusion Criteria:
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Normal care - Prontosan
Patient wounds will be irrigated using the in-use product (Prontosan)
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Irrigation of wound using Prontosan
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Experimental: Investigational arm - Electrolysed water
Patient wounds will be irrigated using electrolysed water
|
Irrigation of wound using electrolysed water
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of complete wound healing
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Dancer (MBBS, FRCP), MD, NHS Lanarkshire
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEWfeet_01
- L16077 (Other Identifier: NHS Lanarkshire)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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