A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT01270633 |
Recruitment Status
:
Terminated
(Business Decision)
First Posted
: January 5, 2011
Last Update Posted
: December 2, 2017
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Sponsor:
Integra LifeSciences Corporation
Information provided by (Responsible Party):
Integra LifeSciences Corporation
Tracking Information | ||||
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First Submitted Date ICMJE | January 4, 2011 | |||
First Posted Date ICMJE | January 5, 2011 | |||
Last Update Posted Date | December 2, 2017 | |||
Study Start Date ICMJE | December 2010 | |||
Actual Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ] Percent of study ulcers healed at week 12 post-randomization
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01270633 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Cost of Treatment [ Time Frame: 12 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers | |||
Official Title ICMJE | A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers | |||
Brief Summary | The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation. | |||
Detailed Description | Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Foot Ulcer, Diabetic | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
25 | |||
Actual Study Completion Date | September 2017 | |||
Actual Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01270633 | |||
Other Study ID Numbers ICMJE | TEI-004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Integra LifeSciences Corporation | |||
Study Sponsor ICMJE | Integra LifeSciences Corporation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Integra LifeSciences Corporation | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |