Study Stopped
Budgetary
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
1 other identifier
interventional
N/A
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2009
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedApril 5, 2017
April 1, 2017
2.3 years
July 24, 2009
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing pathway markers
baseline, day 0, 3, wk 1, 2
Secondary Outcomes (1)
Bacterial Bioburder
baseline, day 0, 3, wk 1, 2
Study Arms (2)
compression therapy
NO INTERVENTIONBiologic with compression therapy
ACTIVE COMPARATORInterventions
collagen based, decellularized equine pericardial dressing for skin surface wounds
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxter Healthcare Corporationlead
- Synovis Surgical Innovationscollaborator
Study Sites (3)
UCSD Medical Center
San Diego, California, 92103, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Newbridge Medical Research Corp., Warren General Hosp.
Warren, Pennsylvania, 16365, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gerit Mulder, DPM
UCSD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2009
First Posted
August 6, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
April 5, 2017
Record last verified: 2017-04