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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02929056
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18 years or older
2. At least one VLU with a total surface area between 2 cm2 and 100 cm2
3. VLU present for at least 1 month
4. Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones
5. Ulcer has a clean, granulating base with minimal adherent slough
6. VLU has been treated with compression therapy for at least 14 days
7. The study VLU has \< 30% area reduction with SOC treatment for the duration ≥ 2 weeks screening period
8. At least one of the following within the last 6 months:
* An Ankle-Brachial Index (ABI) of \> 0.75
* Dorsalis Pedis (DP) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb
* Posterior Tibial (PT) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb
* Great toe systolic pressure ≥ 40 mm Hg
9. Willingness to comply with the protocol, attend all follow-up visits, complete all protocol related assessments and provide informed consent
Exclusion Criteria:
1. Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics
2. Ulcer caused by a medical condition other than venous insufficiency
3. Ulcer suspicious for cancer
4. Known history of AIDS or HIV
5. Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months on the target VLU.
6. Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days
7. Known sensitivity to ethanol
8. Uncontrolled diabetes mellitus with a HgBA1c of \> 10% within the past 3 months
9. Rheumatoid arthritis
10. Significant lower extremity arterial occlusive disease that would preclude the use of compression therapy
11. NYHA Class III and IV congestive heart failure (CHF)
12. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
13. Currently receiving radiation therapy or chemotherapy
14. Receiving immune modulators
15. Currently pregnant or trying to get pregnant
16. Breast feeding
17. Not willing to provide written informed consent or remain in compliance with the study protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02929056
Study Brief:
Protocol Section:
NCT02929056