A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
NCT ID: NCT02120755
Last Updated: 2016-03-03
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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
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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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AmnioClear™
AmnioClear™ Human Allograft Amniotic Membrane
AmnioClear™ Human Allograft Amniotic Membrane
Standard of Care
Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing)
No interventions assigned to this group
Interventions
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AmnioClear™ Human Allograft Amniotic Membrane
Eligibility Criteria
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Inclusion Criteria
* At least one chronic diabetic ulcer
* Full-thickness ulcer size from 1-8 cm2.
Exclusion Criteria
* Bleeding disorders
* Ulcer with muscle, tendon, capsule or bone involvement
18 Years
ALL
Yes
Sponsors
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Liventa Bioscience
INDUSTRY
Responsible Party
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Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Amn-DFU-01
Identifier Type: -
Identifier Source: org_study_id
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