A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
NCT ID: NCT01612806
Last Updated: 2024-04-01
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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TERMINATED
NA
31 participants
INTERVENTIONAL
2011-06-30
2017-02-28
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
NONE
Study Groups
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PriMatrix
PriMatrix Dermal Repair Scaffold
PriMatrix
fetal bovine dermal scaffold
moist wound therapy
standard of care moist wound therapy
PriMatrix Ag
PriMatrix Ag Antimicrobial Dermal Repair Scaffold
PriMatrix Ag
fetal bovine dermal scaffold with Ag
moist wound therapy
standard of care moist wound therapy
Standard of Care
Standard of Care Moist Wound Therapy
moist wound therapy
standard of care moist wound therapy
Interventions
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PriMatrix
fetal bovine dermal scaffold
PriMatrix Ag
fetal bovine dermal scaffold with Ag
moist wound therapy
standard of care moist wound therapy
Eligibility Criteria
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Inclusion Criteria
* Ankle-brachial index (ABI) \> 0.80
* Study wound 2-64 cm2 surface area
* Wound does not exhibit a greater than 50% reduction in surface area during the screening period
Exclusion Criteria
* Hypersensitivity to bovine collagen
* Body Mass Index (BMI) ≥ 45
18 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John Starinski, DPM
Role: STUDY_DIRECTOR
TEI
Locations
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Caribbean Clinical Trials
San Juan, PR, Puerto Rico
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, , Puerto Rico
Doctors' Center Hospital of San Juan
San Juan, , Puerto Rico
Wound and Ulcer Care Clinic of San Juan
San Juan, , Puerto Rico
Wilma N. Vazquez Hospital
Vega Baja, , Puerto Rico
Countries
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Other Identifiers
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TEI-006
Identifier Type: -
Identifier Source: org_study_id
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