Porcine Placental Extracellular Matrix for Venous Leg Ulcers

Overseen By Andrea Picchietti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ConvaTec Inc.

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy, Biologics

Disqualifiers: Infection, Osteomyelitis, DVT, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new treatment, made from porcine placental extracellular matrix (PPECM or InnovaMatrix AC), heals stubborn venous leg ulcers (VLUs) compared to usual care. Participants will receive either standard treatments, such as compression and cleansing, or those treatments plus the new experimental device. The trial seeks individuals with a venous leg ulcer persisting for at least four weeks without significant improvement despite typical care. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications like immunosuppressants or high doses of corticosteroids, as these may interfere with wound healing.

What prior data suggests that this device is safe for treating venous leg ulcers?

Research has shown that a treatment made from pig placenta, known as porcine placental extracellular matrix (PPECM) or InnovaMatrix® AC, aids in healing difficult wounds. Studies have found this treatment to be generally safe and well-tolerated, with no major safety issues reported. The pig placenta undergoes careful processing to ensure safety for human use. While these results are encouraging, individual reactions may vary. Consulting a healthcare professional is advisable for any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the porcine placental extracellular matrix for treating venous leg ulcers because it offers a unique approach compared to traditional treatments. Unlike standard care, which mainly focuses on compression, debridement, and moisture control, this treatment uses a biological material derived from pig placenta to potentially enhance healing. The extracellular matrix provides a scaffold that supports cell growth and tissue regeneration, aiming to improve wound healing more effectively and quickly. This innovative method could offer a new and promising solution for patients who struggle with chronic ulcers.

What evidence suggests that porcine placental extracellular matrix is effective for venous leg ulcers?

This trial will compare porcine placental extracellular matrix (PPECM) with standard care for venous leg ulcers. Studies have shown that PPECM can aid in healing difficult-to-treat wounds. Specifically, research found that patients with diabetic foot ulcers using PPECM had a significantly higher chance of wound healing compared to those who did not. Another study examined real-world outcomes and found that PPECM effectively closed stubborn wounds unresponsive to other treatments. This suggests that PPECM might also accelerate healing and closure of venous leg ulcers. ^{1 3 4 6 7}

Who Is on the Research Team?

Thomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Are You a Good Fit for This Trial?

The INNOVEN trial is for adults over 21 with venous leg ulcers that haven't improved much in the last month. The ulcer should be between 1 and 25 cm2, present for at least 4 weeks but not treated with high-level compression for more than a year. Participants need adequate blood flow to their legs as shown by specific tests.

Inclusion Criteria

My ankle-brachial index (ABI) is between 0.7 and 1.3.

My heart's pulmonary valve has a biphasic flow pattern.

I am 21 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Porcine Placental Extracellular Matrix plus Standard of Care or Standard of Care alone for venous leg ulcers

12 weeks

Weekly visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

12 months

Visits at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Porcine Placental Extracellular Matrix

Trial Overview This study compares two approaches to healing venous leg ulcers: one group receives an innovative treatment using porcine placental extracellular matrix (PPECM) plus standard care, while the other group gets standard care alone. It's a randomized controlled trial, meaning participants are randomly assigned to groups.

How Is the Trial Designed?

Group I: Standard of Care plus Interventional Device Experimental Treatment 1 Intervention

Weekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance,

Group II: Standard of Care Active Control 1 Intervention

Compression, debridement, reduction of bacterial burden, and proper moisture balance.

Porcine Placental Extracellular Matrix is already approved in United States for the following indications:

Approved in United States as InnovaMatrix AC for:

• Pressure ulcers
• Diabetic foot ulcers
• Venous leg ulcers
• Chronic vascular ulcers
• Surgical wounds
• Partial/full-thickness wounds
• Trauma wounds

Who Is Running the Clinical Trial?

ConvaTec Inc.

Lead Sponsor

Trials

52

Recruited

5,900+

Published Research Related to This Trial

A new method successfully isolates extracellular matrix from human placenta (pECM), which is rich in collagen and other important proteins, and can be shaped into stable 3-D structures for potential medical use.

Placenta-derived adherent cells (PDACs) not only bind to the pECM but also proliferate and secrete key cytokines that enhance wound healing, suggesting that combining pECM with PDACs could be an effective treatment for nonhealing wounds and diabetic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placenta Derived Adherent Cell (PDAC) Interaction and Response on Extracellular Matrix Isolated from Human Placenta t. Bhatia, M., Lugo, C., Pereira, M., et al.[2015]

Extracellular matrix-based approaches, particularly those using placental tissues, are gaining attention for their potential to enhance wound healing due to their rich composition of proteins and other healing components.

This mini-review compares four commercially available placental connective matrices (Axiofill, Dermavest, Plurivest, and Interfyl) and discusses their effectiveness in wound healing applications, highlighting the importance of placental disc characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connective tissue matrices from placental disc for wound healing: mini-review. Ganesh, P., Puranik, S., Abhaya, M., et al.[2023]

In a study involving 21 men with chronic venous leg ulcers (VLUs) that had not healed after at least 12 weeks of standard therapy, the application of a human viable wound matrix (hVWM) from cryopreserved placental tissue led to complete healing in 53% of cases.

The use of hVWM resulted in a significant average reduction in ulcer size of 79% over approximately 11 weeks, with a healing rate of 1.69% per day, compared to only 0.73% per day with standard therapy, demonstrating its superior efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. Farivar, BS., Toursavadkohi, S., Monahan, TS., et al.[2020]

A fresh human placental membrane allograft was successfully used to heal a chronic venous ulcer in an 89-year-old woman, demonstrating its potential effectiveness in treating long-standing wounds.

After 60 days of treatment, the ulcer was completely healed, indicating that the amniochorionic membrane can be a viable therapeutic option for chronic vascular ulcers that do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft Piamo, A., García, M., Romero, D., et al.[2023]

Extracellular matrix products used as dressings or topical treatments for leg ulcers show promise in improving healing outcomes compared to standard compression therapy alone.

This review synthesizes evidence from various studies involving adults over 18, indicating that these products may enhance treatment effectiveness for venous, arterial, and mixed leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of extracellular matrix dressings and topical agents in the treatment of leg ulcers: a systematic review protocol. de Fátima Cordeiro Petz, F., Meier, MJ., Roehrs, H., et al.[2023]

In a short-term clinical study involving 18 patients with chronic varicose ulcers, those treated with purified angiogenic and growth factors from human term placenta showed significant increases in granulation and epithelial tissue after treatment.

The findings suggest that these placental factors could be effective in accelerating wound healing, indicating a potential new therapeutic approach for chronic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placental angiogenic and growth factors in the treatment of chronic varicose ulcers: preliminary communication. Burgos, H., Herd, A., Bennett, JP.[2022]

Decellularized porcine placental scaffolds from three different breeds (Landrace, York, and Duroc) maintained their extracellular matrix structure and key basement membrane components, indicating their potential for use in tissue engineering.

The mechanical properties of these scaffolds were found to be similar across the breeds and remained stable for 24 months, suggesting they could be reliable materials for clinical applications like musculotendinous reconstruction and wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The composition and mechanical properties of porcine placental ECM from three different breeds. Capella-Monsonís, H., Cramer, M., Turner, N., et al.[2023]

The human placenta-derived extracellular matrix (hPM) promotes both vasculogenesis in vitro and angiogenesis in vivo, showing potential as a powerful tool for enhancing blood vessel formation in engineered tissues.

In vivo studies demonstrated that hPM-dosed bioscaffolds not only improved angiogenesis but also significantly reduced fibrosis compared to existing biomaterials, suggesting its clinical relevance in regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel human-derived extracellular matrix induces in vitro and in vivo vascularization and inhibits fibrosis. Moore, MC., Pandolfi, V., McFetridge, PS.[2018]

Placental-derived biomaterials are effective in promoting wound healing due to their biocompatibility and properties that support tissue repair, such as anti-inflammatory and antimicrobial effects.

Despite their proven safety and efficacy in wound management, variations in the source and processing of these biomaterials need further investigation to optimize their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placental-Derived Biomaterials and Their Application to Wound Healing: A Review. Protzman, NM., Mao, Y., Long, D., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39720774/

Real-World Use and Outcomes of Hard-To-Heal Wounds ... This study retrospectively analyzed the real-world performance of porcine placental extracellular matrix (PPECM; InnovaMatrix® AC, Convatec ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06606210?term=innoven&intr=venous%20ulcer&rank=1

Efficacy of Porcine Placental Extracellular Matrix Plus ... INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11668260/

Real-World Use and Outcomes of Hard-To-Heal Wounds ... This study retrospectively analyzed the real-world performance of porcine placental extracellular matrix (PPECM; InnovaMatrix® AC, Convatec ...

4. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2025-0092

Comparative effectiveness of porcine placental ... Patients with diabetic foot ulcers who received porcine placental extracellular matrix (PPECM) showed significantly lower relative risk for ...

5. convatecgroup.com convatecgroup.com/media-articles/press-releases/2024/convatec_update_on_innovamatrix_ac_clinical_data_second_randomised_controlled_trial_authorised/

Convatec update on InnovaMatrix® AC clinical data InnovaMatrix® AC is a pioneering technology in the treatment of wounds and is the first-ever porcine placental-derived extracellular matrix (ECM) medical device ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07170566

A Retrospective, Observational Study of the Real-world ... The composition of InnovaMatrix® AC includes the amnion and chorion from the porcine placenta. The safety and performance of the predicate ...

7. mdpi.com mdpi.com/2077-0383/14/19/6823

Real-World Use of a Decellularized Porcine Placental ... This study aimed to assess the real-world efficacy of a novel porcine placental extracellular matrix (PPECM; InnovaMatrix® AC, Convatec, Memphis, TN, USA).