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

This study has suspended participant recruitment.
(Site selection)
Sponsor:
Information provided by (Responsible Party):
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01612806
First received: June 4, 2012
Last updated: May 11, 2015
Last verified: February 2013

June 4, 2012
May 11, 2015
June 2011
February 2017   (final data collection date for primary outcome measure)
Percent of VLUs healed by week 12 post-randomization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01612806 on ClinicalTrials.gov Archive Site
Cost of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Cost of treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
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

To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

Healing percentages

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Stasis Ulcer
  • Device: PriMatrix
    fetal bovine dermal scaffold
  • Device: PriMatrix Ag
    fetal bovine dermal scaffold with Ag
  • Procedure: moist wound therapy
    standard of care moist wound therapy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
31
February 2017
February 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT01612806
TEI-006
No
TEI Biosciences Inc.
TEI Biosciences Inc.
Not Provided
Study Director: John Starinski, DPM TEI
TEI Biosciences Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP