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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01612806
Recruitment Status : Terminated (Site selection)
First Posted : June 6, 2012
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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

Condition or disease Intervention/treatment
Venous Stasis Ulcer Device: PriMatrix Device: PriMatrix Ag Procedure: moist wound therapy

Detailed Description:
Healing percentages

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2011
Primary Completion Date : February 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PriMatrix
PriMatrix Dermal Repair Scaffold
Device: PriMatrix
fetal bovine dermal scaffold
Procedure: moist wound therapy
standard of care moist wound therapy
Experimental: PriMatrix Ag
PriMatrix Ag Antimicrobial Dermal Repair Scaffold
Device: PriMatrix Ag
fetal bovine dermal scaffold with Ag
Procedure: moist wound therapy
standard of care moist wound therapy
Active Comparator: Standard of Care
Standard of Care Moist Wound Therapy
Procedure: moist wound therapy
standard of care moist wound therapy



Primary Outcome Measures :
  1. Percent of VLUs healed by week 12 post-randomization [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Cost of treatment [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612806


Locations
Puerto Rico
Caribbean Clinical Trials
Hato Rey, Puerto Rico, 00918
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, Puerto Rico, 00717
Doctors' Center Hospital of San Juan
San Juan, Puerto Rico, 00918
Wound and Ulcer Care Clinic of San Juan
San Juan, Puerto Rico, 00918
Wilma N. Vazquez Hospital
Vega Baja, Puerto Rico, 00694
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Study Director: John Starinski, DPM TEI

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01612806     History of Changes
Other Study ID Numbers: TEI-006
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis