A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
NCT ID: NCT01228526
Last Updated: 2016-08-26
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
22 participants
OBSERVATIONAL
2010-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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PriMatrix
Eligibility Criteria
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Inclusion Criteria
* Peripheral neuropathy
* A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening
Exclusion Criteria
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Samuel Merritt University
OTHER
New York College of Podiatric Medicine
OTHER
Temple University
OTHER
Circleville Foot & Ankle LLC
UNKNOWN
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Kavros, DPM
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States
Mayo Clinic
Rochester, Minnesota, United States
New York College of Podiatric Medicine
New York, New York, United States
Circleville Foot & Ankle
Circleville, Ohio, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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TEI-003
Identifier Type: -
Identifier Source: org_study_id
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