The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
NCT ID: NCT01228500
Last Updated: 2016-05-17
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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WITHDRAWN
NA
INTERVENTIONAL
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Experimental Arm (Internal Control)
One-half of ulcer receives negative pressure wound therapy
One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy
PriMatrix
Dermal Repair Scaffold
Interventions
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PriMatrix
Dermal Repair Scaffold
Eligibility Criteria
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Inclusion Criteria
* Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
* Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
* Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
* All ulcer durations will be eligible
* Patients currently receiving NPWT for a diabetic foot ulcer
* Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.
Exclusion Criteria
* Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
* Patients who are pregnant
* Allergies to any material contained within the NPWT or bioscaffold
* Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Cook, DPM
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, Harvard Medical School
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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TEI-001
Identifier Type: -
Identifier Source: org_study_id
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