Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs

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

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Other: GrafixPL
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment Exclusion Criteria: 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 A1c (HbA1c) 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 ≥ 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GrafixPL<br> | Other: GrafixPL<br>* Debridement, GrafixPL application, dressing application, standard compression therapy<br>* Other names: Tissue Allograft;|
| Active Comparator: Control<br> | Other: Control<br>* Debridement, dressing application, standard compression therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete closure of the index ulcer |  | Up to 84 days after the Baseline Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial ulcer closure |  | Up to 84 days after the Baseline Visit | 
| Measurement of percent area reduction in ulcers that do not achieve closure |  | 84 days after the Baseline Visit | 
| Proportion of patients with ulcer reoccurrence in Follow-Up Phase |  | Up to 6 months after initial ulcer closure | 
| Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure |  | Up to 91 days after initial Treatment Phase | 
| Time to initial ulcer among patients in the Crossover Extension Treatment Phase |  | Up to 91 days after initial Treatment Phase |