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Trial record 1 of 1 for:    NCT03629236
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Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers

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ClinicalTrials.gov Identifier: NCT03629236
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Osiris Therapeutics

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Other: GrafixPL Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GrafixPL Other: GrafixPL
Debridement, GrafixPL application, dressing application, standard compression therapy
Other Name: Tissue Allograft

Active Comparator: Control Other: Control
Debridement, dressing application, standard compression therapy




Primary Outcome Measures :
  1. Complete closure of the index ulcer [ Time Frame: Up to 84 days after the Baseline Visit ]

Secondary Outcome Measures :
  1. Time to initial ulcer closure [ Time Frame: Up to 84 days after the Baseline Visit ]
  2. Measurement of percent area reduction in ulcers that do not achieve closure [ Time Frame: 84 days after the Baseline Visit ]
  3. Proportion of patients with ulcer reoccurrence in Follow-Up Phase [ Time Frame: Up to 6 months after initial ulcer closure ]
  4. Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure [ Time Frame: Up to 91 days after initial Treatment Phase ]
  5. Time to initial ulcer among patients in the Crossover Extension Treatment Phase [ Time Frame: Up to 91 days after initial Treatment Phase ]

Other Outcome Measures:
  1. Number and type of AEs and SAEs [ Time Frame: Through study completion, approximately 38 weeks ]
  2. Number and type of ulcer related complications [ Time Frame: Through study completion, approximately 38 weeks ]
  3. CWIS Questionnaire [ Time Frame: Through study completion, approximately 38 weeks ]
  4. WPAI Questionnaire [ Time Frame: Through study completion, approximately 38 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629236


Contacts
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Contact: Molly Saunders 4435451821 msaunders@osiris.com

Locations
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United States, Florida
Integral Clinical Trial Solutions Recruiting
Doral, Florida, United States, 33126
Contact: Alejandro Viloria         
United States, Massachusetts
SSH Not yet recruiting
Weymouth, Massachusetts, United States, 02189
Contact: Molly Saunders         
Sponsors and Collaborators
Osiris Therapeutics
Investigators
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Study Director: Sharron McCulloch Osiris Therapeutics

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Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT03629236     History of Changes
Obsolete Identifiers: NCT03543007
Other Study ID Numbers: Osiris Protocol 360
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: July 2018

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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

Additional relevant MeSH terms:
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Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases