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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT01912092
Eligibility Criteria:
Inclusion Criteria:
* Subject older than 18 years old
* Provision of written consent by the subject themselves
* Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
* Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
* Size of wound \>2 cm2.
* Absence of ischaemia of the lower limb as assessed by :
1. Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
2. Toe pressure \> 50 mmHg.
3. Ankle pressure \> 70 mmHg.
* Capable of following Study instructions.
* Compliant with treatment and in particular with off-loading regime.
* Stable management of their diabetes as defined by an HbA1C (%) of 12%
Exclusion Criteria:
* Subjects who are \<18 years old.
* Subjects with a documented sensitivity to alginates or silver.
* Subjects taking a medication or using a device comprising silver.
* Subjects already taking antibiotics before enrolment
* Subjects undergoing dialysis.
* Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
* Pregnancy
* Breast-feeding
* Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01912092
Study Brief:
Protocol Section:
NCT01912092