Pressure InjuryNCT06629506
MicroMatrix® Flex in Tunneling Wounds
A study testing MicroMatrix® Flex, MicroMatrix® UBM Particulate and Cytal® Wound Matrix 2-Layer in people with Pressure Injury and Venous Ulcer, run by Integra LifeSciences Corporation at 3 sites in United States.
Trial summary
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection
- What is being tested?
- MicroMatrix® Flex, MicroMatrix® UBM Particulate and Cytal® Wound Matrix 2-Layer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Dec 2024to 31 Aug 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 22 years at the time of consent
- Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use
- Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
- Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form
Who cannot join
- Burn as etiology of wound
- Unmanaged infection and/or osteomyelitis as determined pre-operatively
- Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other
- Patient report of concurrent participation in another clinical trial that would interfere with this study
- Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Northwell Comprehensive Wound Healing Center
Lake Success, New York, 11042
MedStar Health Research Institute Inc.
Washington D.C., District of Columbia, 20007
About this study
Official title: Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
Read the detailed description
The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers, Draining Wound
- Being tested
- MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroMatrix® FlexDevice
MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for one-time use.
MicroMatrix® UBM ParticulateDevice
MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.
Cytal® Wound Matrix 2-LayerDevice
Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with tunneling and/or undermining wounds | Experimental | MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound. Receives: Device: MicroMatrix® Flex; Device: MicroMatrix® UBM Particulate; Device: Cytal® Wound Matrix 2-Layer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative rate of closure of a tunneling or undermining feature
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at 12 weeks or skin graft visit, relative to first visit/application post debridement
Measured: At 12 weeks or skin graft visit
Secondary outcomes (6)
Relative rate of closure of a tunneling or undermining feature
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at each visit, relative to first visit/application post debridement
Measured: First device application through to 12 weeks
Relative rate of overall wound closure
Relative rate of overall wound closure as determined manually, through measurement of volume, using the Kundin method, of managed wound at each visit, relative to first visit/application post debridement
Measured: First device application through to 12 weeks
Relative rate of overall wound closure
Relative rate of overall wound closure per number of treatments received
Measured: First device application through to 12 weeks
Number of wound infections, seromas, and hematomas
Number of wound infections, seromas, and hematomas requiring re-intervention (including incision and drainage)
Measured: First device application through to 12 weeks
Number of managed wounds which require removal of devices
Number of managed wounds which require removal of devices due to complications, allergic reactions, or intolerance of devices
Measured: First device application through to 12 weeks
Length of stay in-patient
Length of stay in-patient, if applicable
Measured: First device application through to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start12 Dec 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Witherel, Ph.D., Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629506
- Sponsor's protocol ID
- T-MMFLEX-001
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining
- ClinicalTrials.gov ID
- NCT06629506
- Acronym / sponsor ID
- T-MMFLEX-001
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers, Draining Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- 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 safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
Detailed description
The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with tunneling and/or undermining wounds | Experimental | Device: MicroMatrix® Flex, Device: MicroMatrix® UBM Particulate, Device: Cytal® Wound Matrix 2-LayerMicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is ≥ 22 years at the time of consent
- Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use
- Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
- Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form
Key exclusion criteria (5 listed)
- Burn as etiology of wound
- Unmanaged infection and/or osteomyelitis as determined pre-operatively
- Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other
- Patient report of concurrent participation in another clinical trial that would interfere with this study
- Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements
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 |
|---|---|---|
| MicroMatrix® FlexMicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for one-time use. | Device | Subjects with tunneling and/or undermining wounds |
| MicroMatrix® UBM ParticulateMicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use. | Device | Subjects with tunneling and/or undermining wounds |
| Cytal® Wound Matrix 2-LayerCytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use. | Device | Subjects with tunneling and/or undermining wounds |
Primary outcome
Relative rate of closure of a tunneling or undermining feature
Time frame: At 12 weeks or skin graft visit
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at 12 weeks or skin graft visit, relative to first visit/application post debridement
6 secondary outcomes
Relative rate of closure of a tunneling or undermining feature
Time frame: First device application through to 12 weeks
Relative rate of overall wound closure
Time frame: First device application through to 12 weeks
Relative rate of overall wound closure
Time frame: First device application through to 12 weeks
Number of wound infections, seromas, and hematomas
Time frame: First device application through to 12 weeks
Number of managed wounds which require removal of devices
Time frame: First device application through to 12 weeks
Length of stay in-patient
Time frame: First device application through to 12 weeks
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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Claire Witherel, Ph.D. study director
Integra LifeSciences Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroMatrix® Flex, MicroMatrix® UBM Particulate and Cytal® Wound Matrix 2-Layer in people with Pressure Injury and Venous Ulcer, run by Integra LifeSciences Corporation at 3 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 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Relative rate of closure of a tunneling or undermining feature (time frame: At 12 weeks or skin graft visit). 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 5 Mar 2026.