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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01528293
Eligibility Criteria:
Inclusion Criteria:
1. Subjects between 18-75 years of age
2. Subject able and willing to comply with study protocol requirements and able to understand the informed consent
3. Non-pregnant female willing to take urine pregnancy test
4. Chronic venous ulceration of the lower extremity
* Defined: wound of greater than 1 month in duration
* Diagnosis based on clinical assessment and/or venous studies
* \<100 cm2 area and \<10cm at the widest diameter
Exclusion Criteria:
1. Active infection (redness, swelling, pain, purulence)
2. Untreated osteomyelitis or current osteomyelitis
3. Allergy or sensitivity to wound study products
4. Malignancy
5. Plantar surface wounds
6. BMI (Body Mass Index) ≥50
7. Uncontrolled diabetes (HbA1c\>12%) at the time of study screening
8. End stage renal disease
9. Undergoing chemotherapy/radiation therapy
10. Non-dopplerable pedal pulses or otherwise diagnosed with peripheral arterial disease or any contraindication to compression therapy
11. Any previous wound care therapy including negative pressure therapy, ultrasound therapy, BAT, or STSG within the previous 30 days of enrollment; this excludes compression therapy
12. Greater than 35% wound surface area reduction in size at 2 weeks after initial screening visit
13. Pregnancy
14. Subject has any condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
15. Subject unwilling or unable to comply with protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01528293
Study Brief:
Protocol Section:
NCT01528293