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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01913704
Eligibility Criteria:
Inclusion Criteria:
* Patients with superficial venous and mixed aetiology leg ulcers on a flat plane in surface area between 4-50cm2
* Patients with diabetes may be included providing they have good metabolic control
* Patients who understand the trial, agree to adhere to the treatment and are able to give consent
* Patients who can be followed by the same investigating team for the whole period of their participation in the study
Exclusion Criteria:
* Patients who present with wounds which are clinically infected and require antimicrobial therapy. Patients who have been treated for a wound infection with antimicrobial therapy (systematically or topically) may be included providing the wound is no longer assessed as infected and there is a two week wash-out period after the last treatment before the patient is reassessed against the inclusion and exclusion criteria
* Patients with a known sensitivity to any of the components of the evaluation device
* Patients with known or suspected malignancy in the wound or surrounding tissue
* Patients whose wounds show a percentage decrease in surface area of \>25% during the two week screening period
* Patients who do not have the physical or mental capacity, or a significant other with the ability to change the NatroxTM battery pack on a daily basis
* Patients who present with more than 10% of the wound surface area covered in hard eschar
* Patients who are actively treated with immunosuppressive or cortico-steroidal medication
* Patients who are participating in another clinical trial
* Patients with a known history or poor compliance with medical treatment
* Patients who have been in this trial previously and have withdrawn
* Patients who are unable to understand the aims of the trial and do not give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01913704
Study Brief:
Protocol Section:
NCT01913704