Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
NCT ID: NCT01729286
Last Updated: 2016-10-18
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
92 participants
INTERVENTIONAL
2012-09-30
2016-10-31
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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PriMatrix Moist Wound Therapy
sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
PriMatrix Moist Wound Therapy
sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
Standard of Care Moist Wound Therapy
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Standard of Care Moist Wound Therapy
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Standard of Care Moist Wound Therapy
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Interventions
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PriMatrix Moist Wound Therapy
sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
Standard of Care Moist Wound Therapy
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diabetic foot ulcer located on the foot or ankle at least one square centimeter
Exclusion Criteria
* Hypersensitivity to bovine collagen
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_CHAIR
TEI
Locations
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University of Southern California
Los Angeles, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
Advanced Research Institute of Miami
Miami, Florida, United States
Advanced Foot & Ankle Specialists
Tampa, Florida, United States
Joseph M. Still Research Foundation
Augusta, Georgia, United States
American Health Network
Carmel, Indiana, United States
Foot & Andle Center of Mooresville
Mooresville, Indiana, United States
Imperial Health
Lake Charles, Louisiana, United States
Kansas City Vascular
North Kansas City, Missouri, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
North Shore Long Island Jewish Comprehensive Wound Healing Center
Lake Success, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Fairfield Medical Center
Lancaster, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Tennessee
Memphis, Tennessee, United States
Centro Podiatrico del Norte
Arecibo, , Puerto Rico
Renier Gonzalez-Cruz
Juana Díaz, , Puerto Rico
VA Carribean Healthcare System
San Juan, , Puerto Rico
Countries
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Other Identifiers
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TEI-007
Identifier Type: -
Identifier Source: org_study_id
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