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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Porcine Placental Extracellular Matrix for Venous Leg Ulcers?

Research shows that placental tissue, which contains growth factors and stem cells, can help heal chronic wounds like venous leg ulcers. Placental-derived materials have been used for wound healing due to their ability to create a healing environment, and studies have shown increased tissue growth when using placental factors. ^{1 2 3 4 5}

Is Porcine Placental Extracellular Matrix safe for use in humans?

Research indicates that placental-derived biomaterials, including those from porcine sources, have been used safely in wound management for over a century due to their biocompatibility and other beneficial properties. ^{3 5 6 7 8}

How is the treatment Porcine Placental Extracellular Matrix (PPECM) different from other treatments for venous leg ulcers?

Porcine Placental Extracellular Matrix (PPECM) is unique because it uses components from the placenta, which are known for their ability to support tissue repair and regeneration. This treatment provides a scaffold that mimics natural tissue, promoting healing by encouraging cell growth and reducing inflammation, which is different from standard treatments that may not offer these specific biological benefits. ^{1 3 5 6 9}

Research Team

Thomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Placental angiogenic and growth factors in the treatment of chronic varicose ulcers: preliminary communication. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Connective tissue matrices from placental disc for wound healing: mini-review. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of extracellular matrix dressings and topical agents in the treatment of leg ulcers: a systematic review protocol. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Placental-Derived Biomaterials and Their Application to Wound Healing: A Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The composition and mechanical properties of porcine placental ECM from three different breeds. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Placenta Derived Adherent Cell (PDAC) Interaction and Response on Extracellular Matrix Isolated from Human Placenta t. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Novel human-derived extracellular matrix induces in vitro and in vivo vascularization and inhibits fibrosis. [2018]

9. Colombia pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft [2023]