Osiris 360 GrafixPL Prime
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
Synopsis: The primary objective of the present study is to evaluate the safety and efficacy of weekly administration of GrafixPL™ PRIME plus standard compression therapy versus standard compression therapy alone in patients with chronic VLUs.
- 18 years or older, as of the date of screening
- An Index Ulcer that is chronic (defined as present for 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
- Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
- The 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.
- The Index Ulcer has had compression therapy for?:: 2 weeks at Screening Visit 1
- The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
- Patient has adequate circulation to the foot, as documented up to 14 days prior to Screening Visit 1
- Ankle Brachia! Index (ABI) > 0.80 and< 1.30, or
- In patients with non-compressible ankle vessels defined as an ABI 2: 1.30, a Toe Brachia! Index (TBI) 2: 0.50, or
- In patients with non-compressible ankle vessels defined as an ABI 2: 1.30 and TBI cannot be performed (e.g., toe is absent, ulcers are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing)
- Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment
(Baseline Day 0), by either:
Duplex ultrasonography, or
Principal Investigator [PI] clinical assessment to include clinical signs and symptoms of venous ulcerations (e.g., hyperpigmentation of surrounding skin, varicosities, and/or lipodermatosclerosis ).
In the inclusion criteria above, the word or is meant to include the case where both or multiple criteria are met as well as the case where just a single criterion is met.
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is unable to tolerate standard compression therapy
- Glycated hemoglobin Ale (HbAlc) level of> 14% in any patient with type 1 or type 2 diabetes mellitus, as documented up to 14 days prior to Screening Visit 1
- Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
- Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
- Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- Current evidence of infection at the Index Ulcer, including cellulitis and/or pus drainage from the ulcer site at the time of Screening and Baseline Visits
- Evidence of osteomyelitis at the time of Screening and Baseline Visits
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's Index Ulcer has decreased by 2': 30% between Screening Visit 1 and the Baseline Visit during the screening period
- Patient has untreated alcohol or substance abuse at the time of Screening Visit 1
- Pregnant women and women who are breastfeeding
- Patient is currently enrolled in or has participated in another investigational device, drug, or biological trial within 30 days prior to Screening Visit 1
- Patient has had within 14 days of Screening Visit 1, or is currently undergoing, or is planning for ulcer treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
- Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
- Patients who have already been randomized in Protocol 360 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Treatment Study Visit
- Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol
In the exclusion criteria above, the word or is meant to include the case where both or multiple criteria are met as well as the case where just a single criterion is met.