A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers
NCT ID: NCT02081352
Last Updated: 2015-11-05
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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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2014-08-31
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
SINGLE
Study Groups
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DermaPure™
DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.
DermaPure™
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Standard care
Standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.
Standard care
Interventions
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DermaPure™
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Standard care
Eligibility Criteria
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Inclusion Criteria
* Adequate perfusion
* A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
* Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.
Exclusion Criteria
* Presence of infection
* Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
* A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
* Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
* More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
* Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
* Evidence of drug or alcohol abuse,
19 Years
ALL
No
Sponsors
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TRx Wound Care Limited
INDUSTRY
Responsible Party
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Locations
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Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, United States
Associated Foot & Ankle Specialists
Phoenix, Arizona, United States
University of Miami Hospital
Miami, Florida, United States
NYU Langone Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Frykberg
Role: primary
Arthur Tallis, DPM
Role: primary
Robert Kirsner
Role: primary
Ernest Chiu, MD
Role: primary
Howard Kashefsky
Role: primary
Javier LaFontaine, DPM
Role: primary
Joseph Caporusso, DPM
Role: primary
Other Identifiers
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TRG-H01-01
Identifier Type: -
Identifier Source: org_study_id
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