A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Tracking Information
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; (submitted: January 4, 2011)	Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ]; Percent of study ulcers healed at week 12 post-randomization
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; (submitted: January 4, 2011)	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
Condition ICMJE	Foot Ulcer, Diabetic
Intervention ICMJE	Device: PriMatrix Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy; Other: Standard of Care Following sharp debridement, moist wound therapy
Study Arms	Treatment PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy. Intervention: Device: PriMatrix; Active Comparator: Standard of Care Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained. Intervention: Other: Standard of Care
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: November 7, 2012)	30
Original Estimated Enrollment ICMJE; (submitted: January 4, 2011)	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: Men or women ≥ 18 years of age and able to give their own consent; Type I or Type II diabetes with investigator-confirmed reasonable metabolic control; Study ulcer has a Wagner grade of 1 or 2; Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement; A full thickness diabetic foot ulcer located on the foot or ankle; An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening. Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection; Wounds with exposed bone or tendon; Hypersensitivity to bovine collagen
Sex/Gender	Sexes Eligible for Study: All
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	Study Chair: Yiannis Monovoukas, PhD TEI
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