Venous Leg UlcersNCT00953563
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
A study testing Unite Biomatrix in people with Venous Leg Ulcers, run by Baxter Healthcare Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- Unite Biomatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami, Miller School of Medicine
Miami, Florida, 33136
UCSD Medical Center
San Diego, California, 92103
Newbridge Medical Research Corp., Warren General Hosp.
Warren, Pennsylvania, 16365
About this study
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.
- Conditions
- Venous Leg Ulcers
- Being tested
- Unite Biomatrix
- Keywords
- Venous Leg Ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unite BiomatrixDevice
collagen based, decellularized equine pericardial dressing for skin surface wounds
| Study group | Role | What they receive |
|---|---|---|
| compression therapy | No intervention | Not described |
| Biologic with compression therapy | Active comparator | Not described Receives: Device: Unite Biomatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing pathway markers
Measured: baseline, day 0, 3, wk 1, 2
Secondary outcomes (1)
Bacterial Bioburder
Measured: baseline, day 0, 3, wk 1, 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: Budgetary
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Gerit Mulder, DPM, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953563
- Sponsor's protocol ID
- U0802
- Status last verified
- Apr 2017
- First submitted
- 24 Jul 2009
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT00953563
- Acronym / sponsor ID
- U0802
- Conditions
- Venous Leg Ulcers
- Keywords
- Venous Leg Ulcers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Budgetary
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compression therapy | No intervention | – |
| Biologic with compression therapy | Active comparator | Device: Unite Biomatrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unite Biomatrixcollagen based, decellularized equine pericardial dressing for skin surface wounds | Device | Biologic with compression therapy |
Primary outcome
Wound healing pathway markers
Time frame: baseline, day 0, 3, wk 1, 2
1 secondary outcome
Bacterial Bioburder
Time frame: baseline, day 0, 3, wk 1, 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerit Mulder, DPM principal investigator
UCSD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unite Biomatrix in people with Venous Leg Ulcers, run by Baxter Healthcare Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing pathway markers (time frame: baseline, day 0, 3, wk 1, 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.