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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This study has been withdrawn prior to enrollment.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

July 24, 2009
December 12, 2012
March 2009
July 2011   (final data collection date for primary outcome measure)
Wound healing pathway markers [ Time Frame: baseline, day 0, 3, wk 1, 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953563 on ClinicalTrials.gov Archive Site
Bacterial Bioburder [ Time Frame: baseline, day 0, 3, wk 1, 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Leg Ulcers
Device: Unite Biomatrix
collagen based, decellularized equine pericardial dressing for skin surface wounds
  • No Intervention: compression therapy
  • Active Comparator: Biologic with compression therapy
    Intervention: Device: Unite Biomatrix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00953563
U0802
No
Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
Synovis Surgical Innovations
Not Provided
Principal Investigator: Gerit Mulder, DPM UCSD
Synovis Surgical Innovations
July 2011

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