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The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

This study has been withdrawn prior to enrollment.
(Budgetary)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953563
First Posted: August 6, 2009
Last Update Posted: April 5, 2017
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.
Collaborator:
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.

Condition Intervention
Venous Leg Ulcers Device: Unite Biomatrix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Wound healing pathway markers [ Time Frame: baseline, day 0, 3, wk 1, 2 ]

Secondary Outcome Measures:
  • Bacterial Bioburder [ Time Frame: baseline, day 0, 3, wk 1, 2 ]

Enrollment: 0
Study Start Date: March 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: compression therapy
Active Comparator: Biologic with compression therapy Device: Unite Biomatrix
collagen based, decellularized equine pericardial dressing for skin surface wounds

  Eligibility

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:

  • venous ulcer confirmed w/ duplex ultrasound
  • ulcer greater than 6 months duration
  • post-debridement, the ulcer size must be >5cm2
  • at least 18 years old
  • ABI is between 0.7 to 1.2 and/or one of the following:

    • TcPO2 > 30mmHg at the ankle
    • Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
  • able and willing to provide a voluntary written informed consent
  • three or fewer ulcers separated by >3.0 cm distance
  • able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria:

  • greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator
  • ulcer with exposed bone or tendon
  • clinical infection at the studied ulcer site including cellulitis and osteomyelitis
  • ulcer of a non-venous insufficiency etiology
  • phlebitis or deep leg vein thrombosis in past 30 days
  • arterial bypass in previous 30 days
  • severe anemia (Hgb<8)
  • serum albumin <3.0
  • uncompensated congestive heart failure
  • renal failure with Creatinine >2.5mg/dl
  • rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
  • severe liver disease as defined by treating physician
  • uncontrolled diabetes mellitus determined by treating physician
  • malignancy at or near the ulcer site
  • any condition judged by the PI that would cause the study to be detrimental to the patient
  • known allergy to equine derived tissue
  • received another investigational device or drug within 30 days of Day 0
  • radiation therapy at the wound site
  • chemotherapy or immunosuppressive therapy within 30 days of enrollment
  • received another allograft, autograft, xenograft within 30 days of the study
  • pregnant or nursing women
  Contacts and Locations
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): NCT00953563


Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Pennsylvania
Newbridge Medical Research Corp., Warren General Hosp.
Warren, Pennsylvania, United States, 16365
Sponsors and Collaborators
Baxter Healthcare Corporation
Synovis Surgical Innovations
Investigators
Principal Investigator: Gerit Mulder, DPM UCSD
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00953563     History of Changes
Other Study ID Numbers: U0802
First Submitted: July 24, 2009
First Posted: August 6, 2009
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
Venous Leg Ulcers

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases