Management of the Diabetic Foot Using Electrolysed Water (NEWfeet)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02841969|
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot||Other: Electrolysed water Other: Prontosan||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Randomised Double Blind Controlled Trial of Neutral Electrolysed Water vs Conventional Management of Non-healing Diabetic Feet (NEWfeet)|
|Actual Study Start Date :||February 28, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Active Comparator: Normal care - Prontosan
Patient wounds will be irrigated using the in-use product (Prontosan)
Irrigation of wound using Prontosan
Experimental: Investigational arm - Electrolysed water
Patient wounds will be irrigated using electrolysed water
Other: Electrolysed water
Irrigation of wound using electrolysed water
Other Name: Aqualution Salvesan
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841969
|Contact: Raymond Hamill, BScfirstname.lastname@example.org|
|Contact: Lorraine Quinnemail@example.com|
|Principal Investigator:||Stephanie Dancer, MBBS, MD, FRCP||NHS Lanarkshire|