Ulcer VenousNCT06400875

Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU

An observational study of Ulcer Venous and Wound Heal, run by ConvaTec Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcer Venous, Wound Heal
What is being tested?: InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
Type of treatment: Medical device
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 10 Jul 2023to 31 Dec 2025
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study will consist of SerenaGroup® advanced wound care centers or affiliates that will enroll a minimum of 30 subjects.

Who may be able to join

Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of childbearing potential must satisfy the defined contraceptive criteria Exclusion criteria.
Patients who are willing and able to attend all follow-up visits.
Index ulcer characteristics:
Ulcer present for ≥ 30 days prior to (Day 0).
Index ulcer is above the malleolus.
Ulcer greater than or equal to 2cm2 and less than or equal to 20cm2 at the time of enrollment.

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Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:
Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or
ABIs with results of ≥ 0.7 and ≤ 1.2, Or
Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI >1.2 TBI (Toe Brachial Index) > 0.5.
Patient able to ambulate at home or in the clinic with or without mobility aids.
The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping.
The subject is medically stable, in the opinion of the investigator.

Who cannot join

Potential subjects meeting any of the following criteria will be excluded from enrollment
Index Ulcer Assessment:
Penetrates down to muscle, tendon, or bone.
Presence of another venous leg ulcer within 2 cm of the index ulcer
Index ulcer determined to be due to a condition other than venous insufficiency.
Exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.

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Known or suspected local skin malignancy to the index diabetic ulcer.
Wound duration > one year without intermittent closure.
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
In the last 7 days - Hyperbaric oxygen (HBO) therapy
In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or subject is anticipated to require such medications during the course of the study
In the last 30 days - study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem Wound Matrix )
In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
Subject criteria that will make subject ineligible for enrollment:
Known hypersensitivity to porcine based products.
Known osteomyelitis or active cellulitis requiring antimicrobial therapy at wound site.
End stage renal disease requiring dialysis.
Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV
Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.
Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited.
Subjects currently receiving radiation therapy or chemotherapy.
Any pathology that would limit the blood supply and compromise healing or non-revascularizable surgical sites

Trial locations and contacts

1 site in 1 country.

United States1 site

The Serena Group
Cambridge, Massachusetts, 02140

Other trials in United States

About this study

Official title: A Prospective, Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers

Conditions: Ulcer Venous, Wound Heal
Being tested: InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
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® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)Device
weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Wound Area
Assessment of ulcer area (percent area reduction from baseline)
Measured: 12 Weeks

Secondary outcomes (4)

Time to complete wound closure
Time to complete wound closure as defined by FDA.
Measured: 12 Weeks
Rate of wound closure
Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction.
Measured: 12 Weeks
Adverse Events
Incidence of adverse events
Measured: 12 Weeks
Reduction in pain
Assessment of the pain level linked to the wound, using the validated PEG pain scale (0-10), with a higher score indicating more severe pain and pain-related interference with life and activities.
Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202331 Dec 2025

First posted6 May 2024
Study start10 Jul 2023
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcer VenousStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06400875
Sponsor's protocol ID: TLS-IM-002
Status last verified: May 2025
First submitted: 27 Apr 2024
Last updated: 29 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcer Venous trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers
ClinicalTrials.gov ID: NCT06400875
Acronym / sponsor ID: TLS-IM-002
Conditions: Ulcer Venous, Wound Heal
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 37 participants (actual)
Lead sponsor: ConvaTec Inc.Industry (pharma, biotech, devices)
Study start: 10 Jul 2023 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 6 May 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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will consist of SerenaGroup® advanced wound care centers or affiliates that will enroll a minimum of 30 subjects.

Key inclusion criteria (13 listed)

Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of childbearing potential must satisfy the defined contraceptive criteria Exclusion criteria.
Patients who are willing and able to attend all follow-up visits.
Index ulcer characteristics:
Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:
The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping.

Key exclusion criteria (24 listed)

Potential subjects meeting any of the following criteria will be excluded from enrollment
Index Ulcer Assessment:
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
Subject criteria that will make subject ineligible for enrollment:

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® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy	Device	–

Primary outcome

Wound Area
Time frame: 12 Weeks
Assessment of ulcer area (percent area reduction from baseline)

4 secondary outcomes

Time to complete wound closure
Time frame: 12 Weeks
Rate of wound closure
Time frame: 12 Weeks
Adverse Events
Time frame: 12 Weeks
Reduction in pain
Time frame: 12 Weeks

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 29 May 2025.
Individual participant dataSharing planned: Undecided

Related trials for Ulcer Venous

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
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Recruiting
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RecruitingPhase 4
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcer Venous and Wound Heal, 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 13 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 29 May 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?

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?

Wound Area (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06400875.

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 29 May 2025.