Foot Ulcer, DiabeticNCT01858545
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
A study testing MatriStem and Cellular Dermal Replacement Tissue in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 9 sites in United States.
Trial summary
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- MatriStem and Cellular Dermal Replacement Tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Subject has a current diagnosis of type I or type II diabetes
- Subject's ulcer is on the forefoot or heel
- Subject has chronic ulcer - has been present for minimum of 4 weeks
- Subject's ulcer extends through the dermis and into the subcutaneous tissue
- Subject's HgbA1c <12%
- Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest
Major Exclusion Criteria:
- Subject has a known sensitivity to bovine- or porcine-derived products.
- Subject's ulcer is due to a non-diabetic etiology
- Subject's ulcer is over a Charcot deformity of the mid-foot
- Subject's random blood sugar readings are >450 mg/dL
- Subject is on dialysis
- Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Center for Clinical Research Inc.
Castro Valley, California, 94546
Denver VA Medical Center
Denver, Colorado, 80220
Valley Vascular Surgery Associates
Fresno, California, 93720
Advanced Research Institute of Miami
Homestead, Florida, 33030
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140
Carl t. Hayden Phoenix VA Medical Center
Phoenix, Arizona, 85012
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, 85015
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
Read the detailed description
Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- MatriStem, Cellular Dermal Replacement Tissue
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatriStemDevice
MatriStem MicroMatrix and MatriStem Wound Matrix
Cellular Dermal Replacement TissueDevice
Cellular Dermal Replacement Tissue
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | MatriStem MicroMatrix and MatriStem Wound Matrix Receives: Device: MatriStem |
| Comparator | Active comparator | Cellular Dermal Replacement Tissue Receives: Device: Cellular Dermal Replacement Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Wound Closure
Number of participants with incidence of complete wound closure
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Gilbert, PhD, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858545
- Sponsor's protocol ID
- ACL2011-002-I
- Status last verified
- Mar 2021
- First submitted
- 17 May 2013
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01858545
- Acronym / sponsor ID
- ACL2011-002-I
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 29 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
Detailed description
Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: MatriStemMatriStem MicroMatrix and MatriStem Wound Matrix |
| Comparator | Active comparator | Device: Cellular Dermal Replacement TissueCellular Dermal Replacement Tissue |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MatriStemMatriStem MicroMatrix and MatriStem Wound Matrix | Device | Experimental |
| Cellular Dermal Replacement TissueCellular Dermal Replacement Tissue | Device | Comparator |
Primary outcome
Number of Participants With Complete Wound Closure
Time frame: 8 Weeks
Number of participants with incidence of complete wound closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Gilbert, PhD study director
Integra LifeSciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MatriStem and Cellular Dermal Replacement Tissue in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 9 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?
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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Wound Closure (time frame: 8 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 15 Apr 2021.