Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT02841969
Eligibility Criteria:
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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02841969
Study Brief:
Protocol Section:
NCT02841969