- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953563
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
April 4, 2017 updated by: Baxter Healthcare Corporation
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92103
- UCSD Medical Center
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Florida
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Miami, Florida, United States, 33136
- University of Miami, Miller School of Medicine
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Pennsylvania
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Warren, Pennsylvania, United States, 16365
- Newbridge Medical Research Corp., Warren General Hosp.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: compression therapy
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Active Comparator: Biologic with compression therapy
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collagen based, decellularized equine pericardial dressing for skin surface wounds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound healing pathway markers
Time Frame: baseline, day 0, 3, wk 1, 2
|
baseline, day 0, 3, wk 1, 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bacterial Bioburder
Time Frame: baseline, day 0, 3, wk 1, 2
|
baseline, day 0, 3, wk 1, 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerit Mulder, DPM, UCSD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
July 1, 2011
Study Completion (Anticipated)
July 1, 2011
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U0802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Venous Leg Ulcers
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Firstkind LtdCompletedLeg Ulcer | Venous Leg Ulcer | Wound | Wound Leg | Leg Ulcers VenousUnited Kingdom
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DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
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Gloucestershire Hospitals NHS Foundation TrustNot yet recruitingLeg Ulcer | Venous Leg Ulcer | Venous Insufficiency of Leg | Venous Ulcer
-
HealthpointCompletedVenous Leg Ulcer | Venous Stasis UlcersUnited States, Canada
-
Chang Gung Memorial HospitalRecruitingVenous Leg Ulcer | Venous Insufficiency of Leg | Venous Occlusion | Contrast Media ReactionTaiwan
-
University of TurkuUnknown
-
Oneness Biotech Co., Ltd.Taipei Veterans General Hospital, Taiwan; Taipei Medical University Shuang...RecruitingVenous Leg Ulcers (VLU)Taiwan
-
Mansoura UniversityActive, not recruitingVaricose Veins | Venous Insufficiency | Venous Leg Ulcer | Venous RefluxEgypt
-
Macrocure Ltd.UnknownChronic Venous Leg UlcersUnited States
-
Kringle Pharma Europe ABKringle Pharma, Inc.UnknownChronic Venous Leg UlcersNorway, Sweden
Clinical Trials on Unite Biomatrix
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Baxter Healthcare CorporationSynovis Surgical InnovationsTerminatedDiabetic Foot UlcersUnited States
-
Zealand University HospitalUnknownIschemic Heart DiseaseDenmark
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); University of UtahCompletedBinge-Eating DisorderUnited States
-
Kensey Nash CorporationCompletedAcute Knee Cartilage Injury | Tear of Articular Cartilage of Knee, CurrentUnited Kingdom, Italy, Germany, Netherlands
-
Kensey Nash CorporationCompleted
-
Duke Vascular, Inc.TerminatedAbdominal Aortic AneurysmsUnited States
-
Keimyung University Dongsan Medical CenterCompletedMultivessel Coronary Artery DiseaseKorea, Republic of
-
Yonsei UniversityCompletedPercutaneous Coronary Intervention | All-comerKorea, Republic of
-
The University of Hong KongCompletedCoronary Artery DiseaseHong Kong
-
Herlev and Gentofte HospitalZealand University Hospital; DePuy SynthesUnknownProximal Humeral Fracture | Osteoarthritis of the ShoulderDenmark