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

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

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

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Other: GrafixPL; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Doral, Florida, United States, 33126
      • Integral Clinical Trial Solutions
  • Massachusetts
    • Weymouth, Massachusetts, United States, 02189
      • SSH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years or older, as of the date of screening
2. An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
3. Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
4. 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.
5. The Index Ulcer has had compression therapy for > 2 weeks at Screening Visit 1
6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
7. Patient has adequate circulation to the foot, as documented up to 14 days prior to Screening Visit 1
8. Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment

Exclusion Criteria:

1. Index Ulcer is of non-venous pathophysiology
2. Gangrene is present on any part of the affected limb
3. Patient is unable to tolerate standard compression therapy
4. 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
5. Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
6. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
7. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
8. 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
9. Evidence of osteomyelitis at the time of Screening and Baseline Visits
10. Patient has active malignancy other than non-melanoma skin cancer
11. Patient's Index Ulcer has decreased by ≥ 30% between Screening Visit 1 and the Baseline Visit during the screening period
12. Patient has untreated alcohol or substance abuse at the time of Screening Visit 1
13. Pregnant women and women who are breastfeeding
14. Patient is currently enrolled in or has participated in another investigational device, drug, or biological trial within 30 days prior to Screening Visit 1
15. 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
16. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
17. 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
18. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Control; Debridement, dressing application, standard compression therapy
Experimental: GrafixPL	Other: GrafixPL; Debridement, GrafixPL application, dressing application, standard compression therapy; Other Names: Tissue Allograft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Number and type of AEs and SAEs	Through study completion, approximately 38 weeks
Number and type of ulcer related complications	Through study completion, approximately 38 weeks
CWIS Questionnaire	Through study completion, approximately 38 weeks
WPAI Questionnaire	Through study completion, approximately 38 weeks

Collaborators and Investigators

• Sponsor: Osiris Therapeutics
• Investigators: Study Chair: Jaideep Banerjee, PHD, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: Osiris Protocol 360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No