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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT00823095
Eligibility Criteria:
Inclusion Criteria:
* Have a chronic (\> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
* Are 18 years of age or older.
Exclusion Criteria:
* Have had a change in their topical treatment during the last 4 weeks
* Have evidence of Clinical Infection
* Have a transcutaneous oxygen tension \<30mmHg
* Have evidence of the ulcer or infection extending to the underlying muscle or bone.
* Are pregnant.
* Are less than 18 years of age.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00823095
Study Brief:
Protocol Section:
NCT00823095