Venous Stasis UlcerNCT01612806
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
A study testing PriMatrix, PriMatrix Ag and moist wound therapy in people with Venous Stasis Ulcer, run by Integra LifeSciences Corporation at 5 sites in Puerto Rico.
Trial summary
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stasis Ulcer
- What is being tested?
- PriMatrix, PriMatrix Ag and moist wound therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesPuerto Rico
- Study dates
- Jun 2011to Feb 2017
- 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
- Men or women ≥ 18 years of age
- Ankle-brachial index (ABI) > 0.80
- Study wound 2-64 cm2 surface area
- Wound does not exhibit a greater than 50% reduction in surface area during the screening period
Who cannot join
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
- Body Mass Index (BMI) ≥ 45
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Puerto Rico5 sites
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, 00717
Caribbean Clinical Trials
San Juan, PR, 00918
Doctors' Center Hospital of San Juan
San Juan, 00918
Wound and Ulcer Care Clinic of San Juan
San Juan, 00918
Wilma N. Vazquez Hospital
Vega Baja, 00694
About this study
Official title: A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
Read the detailed description
Healing percentages
- Conditions
- Venous Stasis Ulcer
- Being tested
- PriMatrix, PriMatrix Ag, moist wound therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrixDevice
fetal bovine dermal scaffold
PriMatrix AgDevice
fetal bovine dermal scaffold with Ag
moist wound therapyProcedure or surgery
standard of care moist wound therapy
| Study group | Role | What they receive |
|---|---|---|
| PriMatrix | Experimental | PriMatrix Dermal Repair Scaffold Receives: Device: PriMatrix; Procedure: moist wound therapy |
| PriMatrix Ag | Experimental | PriMatrix Ag Antimicrobial Dermal Repair Scaffold Receives: Device: PriMatrix Ag; Procedure: moist wound therapy |
| Standard of Care | Active comparator | Standard of Care Moist Wound Therapy Receives: Procedure: moist wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of VLUs healed by week 12 post-randomization
Measured: 12 weeks
Secondary outcomes (1)
Cost of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Site selection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Stasis UlcerStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Starinski, DPM, Study director, TEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612806
- Sponsor's protocol ID
- TEI-006
- Status last verified
- Mar 2024
- First submitted
- 4 Jun 2012
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01612806
- Acronym / sponsor ID
- TEI-006
- Conditions
- Venous Stasis Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Site selection
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Jun 2012 (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.
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
Detailed description
Healing percentages
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PriMatrix | Experimental | Device: PriMatrix, Procedure: moist wound therapyPriMatrix Dermal Repair Scaffold |
| PriMatrix Ag | Experimental | Device: PriMatrix Ag, Procedure: moist wound therapyPriMatrix Ag Antimicrobial Dermal Repair Scaffold |
| Standard of Care | Active comparator | Procedure: moist wound therapyStandard of Care Moist Wound Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women ≥ 18 years of age
- Ankle-brachial index (ABI) > 0.80
- Study wound 2-64 cm2 surface area
- Wound does not exhibit a greater than 50% reduction in surface area during the screening period
Key exclusion criteria (3 listed)
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
- Body Mass Index (BMI) ≥ 45
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 |
|---|---|---|
| PriMatrixfetal bovine dermal scaffold | Device | PriMatrix |
| PriMatrix Agfetal bovine dermal scaffold with Ag | Device | PriMatrix Ag |
| moist wound therapystandard of care moist wound therapy | Procedure or surgery | PriMatrix, PriMatrix Ag, Standard of Care |
Primary outcome
Percent of VLUs healed by week 12 post-randomization
Time frame: 12 weeks
1 secondary outcome
Cost of treatment
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Site selection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
John Starinski, DPM study director
TEI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PriMatrix, PriMatrix Ag and moist wound therapy in people with Venous Stasis Ulcer, run by Integra LifeSciences Corporation at 5 sites in Puerto Rico.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Puerto Rico. 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 stopped early (reason given: Site selection). Results are not available in the source record.
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?
Percent of VLUs healed by week 12 post-randomization (time frame: 12 weeks). 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 1 Apr 2024.