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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01396304
Eligibility Criteria:
Inclusion Criteria:
1. Is 18 years or older; male or female.
2. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
3. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
4. Has an ankle brachial index (ABI) \>0.8.
5. Has a venous ulcer with duration less than 24 months.
6. Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:
Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
7. Is currently using Profore as their standard of care.
8. Has not received antibiotics for 6 weeks prior to enrollment.
Exclusion Criteria
1. Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid \[carboxymethylceullose\], silver).
2. Is currently on antibiotics.
3. Has a negative venous duplex.
4. Is unable to tolerate 4 layer compression.
5. Is unable to continue contact with the investigator for a period of at least two weeks.
6. Is unwilling or unable to comply with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01396304
Study Brief:
Protocol Section:
NCT01396304