- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260609
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds
February 1, 2016 updated by: Osiris Therapeutics
A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
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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Arizona
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Phoenix, Arizona, United States, 85012
- Carl T. Hayden Medical Research Foundation
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Tucson, Arizona, United States, 85723
- Southern Arizona VA Health Care System
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Florida
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Miami, Florida, United States, 33125
- Miami VA
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Massachusetts
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Weymouth, Massachusetts, United States, 02190
- South Shore Hospital
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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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 18 years and 85 years of age inclusive, as of the date of screening
- Confirmed diagnosis of Type I or Type II Diabetes
- Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
- Wound is located on the foot below the malleoli
- Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
- Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
Patient has adequate circulation to the foot as documented by either:
- Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or
- In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 > 30 mmHg, or
- Skin perfusion pressure > 30 mmHg
Exclusion Criteria:
- Index Wound is of non-diabetic pathophysiology
- Gangrene is present on any part of the affected foot
- Index Wound is over a Charcot deformity
- The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
- Patient has a glycated hemoglobin A1 (HbA1c) level of >14%
- Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
- Patient has a wound within 15cm of the Index Ulcer identified for study consideration
- Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's random blood sugar is >450 mg/dl at screening
- Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator
- Pregnant women
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- Patient has allergy to primary or secondary dressing materials used in this trial
- Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
- In the opinion of the Investigator, the patient is unsuitable for participation in the study
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Open-Label
Grafix®: Cryopreserved Placental Membrane
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The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®. Patients will be treated for up to 16 weeks. Patients will be evaluated at screening and then weekly throughout the study or until wound closure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
100% granulation of wound as determined by the investigator
Time Frame: Up to 16 weeks after the Initial Treatment Visit
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Up to 16 weeks after the Initial Treatment Visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to 100% granulation
Time Frame: Up to 16 weeks after the Initial Treatment Visit
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Up to 16 weeks after the Initial Treatment Visit
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Number of applications of Grafix®
Time Frame: Up to 16 weeks after the Initial Treatment Visit
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Up to 16 weeks after the Initial Treatment Visit
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Measurement of percent wound area reduction as determined by the investigator
Time Frame: Up to 16 weeks after the Initial Treatment Visit
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Up to 16 weeks after the Initial Treatment Visit
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Closure of wound defined by 100% re-epithelialization
Time Frame: Up to 16 weeks after the Initial Treatment Visit
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Up to 16 weeks after the Initial Treatment Visit
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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
October 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 6, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 9, 2014
Study Record Updates
Last Update Posted (Estimate)
February 2, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osiris Protocol 310
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.
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-
HealthpointCompleted
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HealthpointCompletedDiabetic Foot Ulcers | Diabetic Foot WoundsUnited States
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-
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-
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-
Amir AzarpazhoohInstitut Straumann AGCompletedPeriodontal Inflammation | Crown LengtheningCanada
-
Novartis PharmaceuticalsCompletedPulmonary Disease, Chronic Obstructive (COPD)Argentina
-
GuerbetCompletedPrimary Brain TumorColombia, Korea, Republic of, United States, Mexico