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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02395302
Eligibility Criteria:
Inclusion Criteria:
* Subject must be ≥ 18 years of age or legal age at the time of enrollment.
* Chronic venous insufficiency confirmed by ultrasound within previous 12 months.
* Active ulceration (CEAP classification of C6)
* Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with conservative treatment.
* Ulcer size ≥ 2cm2 ≤ 50cm2
* Leg circumferences within the following range:Ankle - 12 to 44cm;Calf - 22 to 60cm; Below knee - 22 to 68cm
Exclusion Criteria:
* Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
* Greater than 3 separate full thickness ulcers on the study limb
* Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
* Treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment.
* History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 3 months.
* Either the dorsalis pedis (DP) or posterior tibial (PT) systolic pressure \< 80mmHg for diabetic patients or \< 60mmHg for non-diabetic patients on study limb or transcutaneous partial pressure oxygen (Tcp02) ≤ 30mmHg or great toe systolic pressure ≤ 40mmHg.
* Acute thrombophlebitis.
* History of pulmonary edema or decompensated congestive heart failure.
* Currently has an active infection of the skin such as cellulitis requiring antibiotics.
* History of cancer within the last 5 years with the exception of treated non-melanoma skin cancer or cervical carcinoma in situ.
* Poorly controlled diabetes with a Hemoglobin A1c (HbA1c) value of \>12%.
* Changes to medications that affect edema within the last 30 days
* Need for current and ongoing therapy with corticosteroids (exception for continued low dose usage) or cytotoxic drugs or the current use of Daflon 500.
* Currently pregnant or trying to become pregnant.
* Inability or unwillingness to participate in all aspects of study protocol.
* Currently participating in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02395302
Study Brief:
Protocol Section:
NCT02395302