A Multicenter Prospective Randomized Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL PRIME for the Treatment of Chronic Venous Leg Ulcers | NYU Langone Health

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A Multicenter Prospective Randomized Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL PRIME for the Treatment of Chronic Venous Leg Ulcers

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Venous Leg Ulcers
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects must be older than 18 years old
2. Subjects has an Index Ulcer that is chronic
3. Subjects must have Index Ulcer is located on the leg, below the knee and above the malleoli
4. Subjects' Index Ulcer is between 1 cm2 and 25 cm2, inclusive, at the Screening and Baseline Visits. The longest dimension of the index ulcer cannot exceed 10 cm at the Baseline Visit
5. Subjects' Index Ulcer has had compression therapy for 2 weeks at Screening Visit 1
6. Subjects' Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
7. Subjects have adequate circulation to the foot
8. Subjects have confirmed diagnosis of venous insufficiency

You may not be eligible for this study if the following are true:

1. Subjects' Index Ulcer is of non-venous pathophysiology
2. Subjects have gangrene on any part of the affected limb
3. Subjects are unable to tolerate standard compression therapy
4. Subjects who have laboratory results as per protocol
5. Subjects who are receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
6. Subjects have an ulcer within 5 cm of the Index Ulcer identified for study consideration
7. Subjects are Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
8. Subjects with Current evidence of infection at the Index Ulcer
9. Subjects has evidence of osteomyelitis
10. Subjects with active malignancy other than non-melanoma skin cancer
11. Subjects who have untreated alcohol or substance abuse at the time of Screening Visit 1
12. Subjects with acute or chronic liver disease with severe impairment of liver function
13. Pregnant women and women who are breastfeeding
14. Subjects who were previous randomized in protocol 360
15. Subjects with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol