Foot Ulcer, DiabeticNCT01270633
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
A study testing PriMatrix in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 8 sites in 2 countries.
Trial summary
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and 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 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
- 30 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2010to Sep 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 and able to give their own consent
- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- Study ulcer has a Wagner grade of 1 or 2
- Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
- A full thickness diabetic foot ulcer located on the foot or ankle
- 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
8 sites in 2 countries.
8 sites in 2 countries
Puerto Rico6 sites
Professional Hospital
Guaynabo, 00717
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
United States2 sites
HyperbaRXs
Cumming, Georgia, 30041
Covenant Medical Center
Saginaw, Michigan, 48602
About this study
Official title: A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
Read the detailed description
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- PriMatrix, Standard of Care
- 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
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
Standard of CareOther
Following sharp debridement, moist wound therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy. Receives: Device: PriMatrix |
| Standard of Care | Active comparator | Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of study ulcers healed
Percent of study ulcers healed at week 12 post-randomization
Measured: 12 weeks post-randomization
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 posted5 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Business Decision
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiannis Monovoukas, PhD, Study chair, TEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270633
- Sponsor's protocol ID
- TEI-004
- Status last verified
- Nov 2017
- First submitted
- 4 Jan 2011
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. 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 For The Treatment Of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01270633
- Acronym / sponsor ID
- TEI-004
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Jan 2011 (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 compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
Detailed description
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: PriMatrixPriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy. |
| Standard of Care | Active comparator | Other: Standard of CareNon adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women ≥ 18 years of age and able to give their own consent
- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- Study ulcer has a Wagner grade of 1 or 2
- Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
- A full thickness diabetic foot ulcer located on the foot or ankle
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 |
|---|---|---|
| PriMatrixFollowing sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy | Device | Treatment |
| Standard of CareFollowing sharp debridement, moist wound therapy | Other | Standard of Care |
Primary outcome
Percent of study ulcers healed
Time frame: 12 weeks post-randomization
Percent of study ulcers healed at week 12 post-randomization
1 secondary outcome
Cost of Treatment
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Yiannis Monovoukas, PhD study chair
TEI
8 sites in 2 countries: 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 8 sites in 2 countries.
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 6 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Puerto Rico, 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 stopped early (reason given: Business Decision). 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 study ulcers healed (time frame: 12 weeks post-randomization). 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 2 Dec 2017.