- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936128
TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers
April 4, 2017 updated by: Osiris Therapeutics
A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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California, California, United States
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Florida
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Florida, Florida, United States
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Massachusetts
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Massachusetts, Massachusetts, United States
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Michigan
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Michigan, Michigan, United States
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North Carolina
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North Carolina, North Carolina, United States
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Pennsylvania
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Pennsylvania, Pennsylvania, United States
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Virginia
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Virginia, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 18 years and 80 years of age inclusive, 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 the Screening Visit)
- Index Ulcer is located on the leg, below the knee
- The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
- The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
- The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
- Wound is free of necrotic debris
- Patient has adequate circulation to the foot as documented by Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
- Confirmed diagnosis of venous insufficiency with duplex ultrasonography to demonstrate reflux of ≥ 0.5 seconds in the superficial lower extremity venous system.
Exclusion Criteria:
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is currently receiving dialysis or planning to go on dialysis
- Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
- Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
- Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
- Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
- 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 cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
- Patient's random blood sugar is > 450 mg/dl at screening
- Patient is unable to receive compression therapy as a part of standard of care
- Patient has untreated alcohol or substance abuse at the time of screening
- Pregnant women and women who are breastfeeding
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- Patient has had within the last 30 days, or is currently undergoing, or is planning for wound 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 352 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
- Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TruSkin®
Cryopreserved skin allograft
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Active Comparator: Wound Cover
Active Comparator for Venous Leg Ulcers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients that achieve complete closure of the index wound by 12 weeks
Time Frame: 12 weeks
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12 weeks
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Time to initial wound closure
Time Frame: Up to 84 days
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Up to 84 days
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Number of product applications
Time Frame: Up to 84 days
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Up to 84 days
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Number of AEs
Time Frame: Up to 84 days
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Up to 84 days
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Number of patients with worsening of index wound defined by ≥ 50% increase in wound size
Time Frame: Up to 84 days
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Up to 84 days
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Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
April 6, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osiris Protocol 352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Venous Leg Ulcers
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Macrocure Ltd.UnknownChronic Venous Leg UlcersUnited States
-
Kringle Pharma Europe ABKringle Pharma, Inc.UnknownChronic Venous Leg UlcersNorway, Sweden
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Tactile MedicalCompletedVenous Insufficiency | Venous Leg Ulcer | Chronic Venous Insufficiency | Venous Ulcer | Venous Stasis UlcerUnited States
-
Ohio State UniversityNational Institute on Aging (NIA)RecruitingChronic Venous Leg UlcersUnited States
-
Kingfisher HealthcareUnknownChronic Venous Leg UlcersBelgium
-
Professor Stewart WalshCompletedChronic Venous DiseaseIreland
-
Firstkind LtdCompletedLeg Ulcer | Venous Leg Ulcer | Wound | Wound Leg | Leg Ulcers VenousUnited Kingdom
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DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
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Gloucestershire Hospitals NHS Foundation TrustNot yet recruitingLeg Ulcer | Venous Leg Ulcer | Venous Insufficiency of Leg | Venous Ulcer
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SoftOx Solutions ASCompletedVenous Leg Ulcer | Chronic Leg UlcerDenmark
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