GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
NCT ID: NCT02675855
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2016-01-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GrafixPRIME®
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
GrafixPRIME®
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Off-loading (walking boot)
Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
Active Comparator
Wound cover, Dressing Application Patients will be fitted with off-loading devices
Dressing Application
Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Off-loading (walking boot)
Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
Interventions
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GrafixPRIME®
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Dressing Application
Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Off-loading (walking boot)
Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
Eligibility Criteria
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Inclusion Criteria
* Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks)
* Index ulcer located below the malleoli on the plantar or dorsal surface of the foot
* Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule
* Adequate circulation to the foot (documented by ABI or TBI)
Exclusion Criteria
* Index ulcer is over a Charcot deformity
* Patient is receiving dialysis
* Patient has 2 or more previous amputations
* Patient has HbA1c \>12% or random blood sugar \>450 mg/dl
* Chronic oral steroid use
* Use of IV corticosteroid, immunosuppressive, or cytotoxic agents
* IV antibiotics
* Another ulcer within 5cm of the Index ulcer
* Cellulitis, evidence of infection, or osteomyelitis
18 Years
80 Years
ALL
No
Sponsors
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Osiris Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Sharron McCulloch
Role: STUDY_DIRECTOR
Director, Clinical Affairs
Locations
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Arizona City, Arizona, United States
California City, California, United States
New Mexico, New Mexico, United States
Countries
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Other Identifiers
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Protocol 350
Identifier Type: -
Identifier Source: org_study_id
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