Foot Ulcers, DiabeticNCT01228526
A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
An observational study of Foot Ulcers, Diabetic, run by Integra LifeSciences Corporation at 5 sites in United States.
Trial summary
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcers, Diabetic
- What is being tested?
- PriMatrix
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to Sep 2012
- Phase
- Observational
- 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
Study population: Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria
Who may be able to join
- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- Peripheral neuropathy
- A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
- An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening
Who cannot join
- Suspected or confirmed signs/symptoms of wound infection
- Wounds with exposed bone or tendon
- Hypersensitivity to bovine collagen
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Circleville Foot & Ankle
Circleville, Ohio, 43113
New York College of Podiatric Medicine
New York, New York, 10035
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, 94609
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota
About this study
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
- Conditions
- Foot Ulcers, Diabetic
- Being tested
- PriMatrix
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrixDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of study ulcers healed
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcers, DiabeticStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Samuel Merritt University, New York College of Podiatric Medicine, Temple University, Circleville Foot & Ankle LLC
- Responsible party
- Sponsor
- Investigators
- Steven Kavros, DPM, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228526
- Sponsor's protocol ID
- TEI-003
- Status last verified
- Aug 2016
- First submitted
- 25 Oct 2010
- Last updated
- 26 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01228526
- Acronym / sponsor ID
- TEI-003
- Conditions
- Foot Ulcers, Diabetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Samuel Merritt University, New York College of Podiatric Medicine, Temple University, Circleville Foot & Ankle LLC
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Oct 2010 (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 in the treatment of DFUs in subjects without significantly compromised arterial circulation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- Peripheral neuropathy
- A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
- An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening
Key exclusion criteria (3 listed)
- Suspected or confirmed signs/symptoms of wound infection
- Wounds with exposed bone or tendon
- Hypersensitivity to bovine collagen
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 |
|---|---|---|
| PriMatrix | Device | – |
Primary outcome
Percent of study ulcers healed
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
Steven Kavros, DPM principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Ulcers, Diabetic, run by Integra LifeSciences Corporation at 5 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 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: finished, as of the sponsor's last update on 26 Aug 2016. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 study ulcers healed (time frame: Week 12). 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 26 Aug 2016.