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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00953563
First received: July 24, 2009
Last updated: December 12, 2012
Last verified: July 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Synovis Surgical Innovations:

Primary Outcome Measures:
  • Wound healing pathway markers [ Time Frame: baseline, day 0, 3, wk 1, 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial Bioburder [ Time Frame: baseline, day 0, 3, wk 1, 2 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Synovis Surgical Innovations
Investigators
Principal Investigator: Gerit Mulder, DPM UCSD
  More Information

No publications provided

Responsible Party: Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00953563     History of Changes
Other Study ID Numbers: U0802
Study First Received: July 24, 2009
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
Venous Leg Ulcers

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

ClinicalTrials.gov processed this record on November 27, 2014