A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

TEI Biosciences Inc.

ClinicalTrials.gov Identifier:

NCT01612806

First received: June 4, 2012

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 4, 2012
Last Updated Date	February 21, 2013
Start Date ^ICMJE	June 2011
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 5, 2012)	Percent of VLUs healed by week 12 post-randomization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01612806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 9, 2013)	Cost of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 5, 2012)	Cost of treatment [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
Official Title ^ICMJE	A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers
Brief Summary	To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Venous Stasis Ulcer
Intervention ^ICMJE	Device: PriMatrix Device: PriMatrix Ag Procedure: moist wound therapy
Study Arm (s)	Experimental: PriMatrix PriMatrix Dermal Repair Scaffold Interventions: Device: PriMatrix Procedure: moist wound therapy Experimental: PriMatrix Ag PriMatrix Ag Antimicrobial Dermal Repair Scaffold Interventions: Device: PriMatrix Ag Procedure: moist wound therapy Active Comparator: Standard of Care Standard of Care Moist Wound Therapy Intervention: Procedure: moist wound therapy
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	Completed
Enrollment ^ICMJE	31
Completion Date	Not Provided
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men or women ≥ 18 years of age Ankle-brachial index (ABI) > 0.80 Study wound 2-64 cm2 surface area Wound does not exhibit a greater than 50% reduction in surface area during the screening period Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection Hypersensitivity to bovine collagen Body Mass Index (BMI) ≥ 45
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Puerto Rico

Administrative Information
NCT Number ^ICMJE	NCT01612806
Other Study ID Numbers ^ICMJE	TEI-006
Has Data Monitoring Committee	No
Responsible Party	TEI Biosciences Inc.
Study Sponsor ^ICMJE	TEI Biosciences Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	TEI Biosciences Inc.
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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