Wound HealNCT06606210
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
A study testing InnovaMatrix® AC in people with Wound Heal and Venous Leg Ulcer, run by ConvaTec Inc. at 1 site in United States.
Trial summary
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Wound Heal, Venous Leg Ulcer
- What is being tested?
- InnovaMatrix® AC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 21 years of age or older.
- At randomization subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The target ulcer must have been present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
- No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to randomization.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
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- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
Who cannot join
- The potential subject is known to have a life expectancy of < 6 months.
- The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
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- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Digital planimetry is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
- The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.
- The potential subject is unable to tolerate therapeutic compression (30-40mmHg).
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- Potential subjects with a sensitivity or allergy to porcine materials or collagen.
- Potential subjects with religious or personal objection to use of porcine- or animal-derived materials.
- A subject with a disorder that would create unacceptable risk of treatment complications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Three Rivers Wound and Hyperbaric Center
North Port, Florida, 34289
Keyur Patel, DO
About this study
Official title: An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care Versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs).
Read the detailed description
An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers.
- Conditions
- Wound Heal, Venous Leg Ulcer
- Being tested
- InnovaMatrix® AC
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnovaMatrix® ACDevice
Also called Porcine Derived Extracellular Matrix
Weekly dressing applications
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Compression, debridement, reduction of bacterial burden, and proper moisture balance. |
| Standard of Care plus Interventional Device | Experimental | Weekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance, Receives: Device: InnovaMatrix® AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks.
The percentage of target ulcers achieving complete wound closure defined as complete epithelialisation of the wound surface.
Measured: 12 weeks
Secondary outcomes (6)
Determine the time to closure for ulcers achieving complete closure over 12-weeks for PPECM+SOC versus SOC alone.
For study ulcers achieving complete closure, the time to closure over the 12-week treatment duration.
Measured: 12 weeks
Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.
Percentage wound area reduction from initial treatment to 12-week measured weekly with digital photographic planimetry.
Measured: 12 weeks
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Measured with Forgotten Wound Score (FWS) questionnaire, assessing the awareness of the wound, ranging from "Never" to "Mostly").
Measured: Day 0, 4 weeks, 8 weeks, and 12 weeks
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Measured with standard Wound Quality of Life (wQOL) questionnaire, assessing how wound care has affected the quality of life in the last seven days, ranging from "Not at all" to "Very much".
Measured: Day 0, 4 weeks, 8 weeks, and 12 weeks
Determine the long-term durability of closure in PPECM+SOC versus SOC alone.
Change in quality of life using the Wound Quality of Life (wQOL) questionnaire, assessing how wound care has affected the quality of life in the last seven days, ranging from "Not at all" to "Very much".
Measured: 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase
Determine the long-term durability of closure in PPECM+SOC versus SOC alone.
Change in quality of life using the Forgotten Wound Score (FWS) questionnaire, assessing the awareness of the wound, ranging from "Never" to "Mostly").
Measured: 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start19 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas E. Serena, MD FACS, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606210
- Sponsor's protocol ID
- WC-24-454
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2024
- Last updated
- 22 Aug 2025
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care Versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT06606210
- Acronym / sponsor ID
- WC-24-454
- Conditions
- Wound Heal, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Sep 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.
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs).
Detailed description
An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Compression, debridement, reduction of bacterial burden, and proper moisture balance. |
| Standard of Care plus Interventional Device | Experimental | Device: InnovaMatrix® ACWeekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance, |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must be at least 21 years of age or older.
- At randomization subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The target ulcer must have been present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
- No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to randomization.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
Key exclusion criteria (20 listed)
- The potential subject is known to have a life expectancy of < 6 months.
- The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
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 |
|---|---|---|
| InnovaMatrix® ACAlso: Porcine Derived Extracellular MatrixWeekly dressing applications | Device | Standard of Care plus Interventional Device |
Primary outcome
Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks.
Time frame: 12 weeks
The percentage of target ulcers achieving complete wound closure defined as complete epithelialisation of the wound surface.
6 secondary outcomes
Determine the time to closure for ulcers achieving complete closure over 12-weeks for PPECM+SOC versus SOC alone.
Time frame: 12 weeks
Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.
Time frame: 12 weeks
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Time frame: Day 0, 4 weeks, 8 weeks, and 12 weeks
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Time frame: Day 0, 4 weeks, 8 weeks, and 12 weeks
Determine the long-term durability of closure in PPECM+SOC versus SOC alone.
Time frame: 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase
Determine the long-term durability of closure in PPECM+SOC versus SOC alone.
Time frame: 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
Thomas E. Serena, MD FACS principal investigator
SerenaGroup, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnovaMatrix® AC in people with Wound Heal and Venous Leg Ulcer, run by ConvaTec Inc. 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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Picchietti (727-247-5234, andrea.picchietti@convatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks. (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 22 Aug 2025.