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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT01442103
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent
2. Both genders with an age \>18 years
3. Subjects with chronic wounds \< 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
* Erythema
* Edema
* Warmth
* Increased drainage
* Foul odor
4. Subject's wounds may also present with:
* presence of eschar or slough that needs to be treated prior to normal standard of care OR
* A need for topical care after debridement
5. Study site to include only ONE wound to be treated
Exclusion Criteria:
1. Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
2. Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
3. Wound \> 1 year old
4. Wound \> 10 cm x 10 cm (l x w)
5. Wound \> 6 cm deep
6. Use of chemical/enzymatic and biological debridement within 7 days of investigation start
7. Necrotizing wounds
8. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
9. Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
10. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
11. Known allergy/hypersensitivity to any of the components of the investigation products.
12. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
13. Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01442103
Study Brief:
Protocol Section:
NCT01442103