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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):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01612806
First received: June 4, 2012
Last updated: May 15, 2016
Last verified: May 2016
  Purpose
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

Condition Intervention
Venous Stasis Ulcer
Device: PriMatrix
Device: PriMatrix Ag
Procedure: moist wound therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Percent of VLUs healed by week 12 post-randomization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Healing percentages
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01612806     History of Changes
Other Study ID Numbers: TEI-006 
Study First Received: June 4, 2012
Last Updated: May 15, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 07, 2016