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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT01567150
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of venous insufficiency
* One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
* Ankle/brachial index 0.8 and above
* Duration of wound up to one year
* Able to return to wound clinic for weekly evaluations
* Has signed Institutional Review Board approved informed consent
Exclusion Criteria:
* Exposed bone or tendon or necrotic wound base
* Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
* Allergy to a component of the novel dressing or compression wrap
* Third degree burn
* Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
* Receiving antibiotics
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01567150
Study Brief:
Protocol Section:
NCT01567150