Foot Ulcer, DiabeticNCT01228500
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
A study testing PriMatrix in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- PriMatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2013
- 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
- Adult Type 1 or 2 diabetic patients that present with foot ulcers.
- Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
- Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
- Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
- All ulcer durations will be eligible
- Patients currently receiving NPWT for a diabetic foot ulcer
- Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.
Who cannot join
- Active foot infections
- Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
- Patients who are pregnant
- Allergies to any material contained within the NPWT or bioscaffold
- Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts
About this study
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- PriMatrix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrixDevice
Dermal Repair Scaffold
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (Internal Control) | Experimental | One-half of ulcer receives negative pressure wound therapy
One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy Receives: Device: PriMatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
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 posted26 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Jeremy Cook, DPM, Principal investigator, Beth Israel Deaconess Medical Center, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228500
- Sponsor's protocol ID
- TEI-001
- Status last verified
- May 2016
- First submitted
- 25 Oct 2010
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT01228500
- Acronym / sponsor ID
- TEI-001
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (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.
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (Internal Control) | Experimental | Device: PriMatrixOne-half of ulcer receives negative pressure wound therapy One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult Type 1 or 2 diabetic patients that present with foot ulcers.
- Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
- Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
- Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
- All ulcer durations will be eligible
Key exclusion criteria (5 listed)
- Active foot infections
- Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
- Patients who are pregnant
- Allergies to any material contained within the NPWT or bioscaffold
- Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
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 |
|---|---|---|
| PriMatrixDermal Repair Scaffold | Device | Experimental Arm (Internal Control) |
Primary outcome
Time to healing
Time frame: 12 weeks
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 17 May 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.
Jeremy Cook, DPM principal investigator
Beth Israel Deaconess Medical Center, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PriMatrix in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 1 site 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 7 inclusion and 5 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to healing (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 17 May 2016.