Porcine Placental Tissue for Diabetic Foot Ulcers

Not currently recruiting at 4 trial locations

Overseen By Kristy Breisinger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ConvaTec Inc.

Must not be taking: Chemotherapy, Corticosteroids, Immunosuppressants, others

Disqualifiers: Charcot deformity, Osteomyelitis, AIDS, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment made from porcine (pig) placental tissue to heal stubborn diabetic foot ulcers that do not improve with usual care. The goal is to determine if InnovaMatrix AC porcine placental ECM therapy is safe and effective when used alongside standard wound care methods. People with long-lasting diabetic foot ulcers, who have diabetes and meet specific ulcer size and location criteria, might be suitable for this study. Participants must consent to using a pig-based product as part of their treatment. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for diabetic foot ulcers.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop certain treatments before joining. You cannot have had negative pressure wound therapy, hyperbaric oxygen therapy, or chemical debridement recently. Also, you must not have used certain medications like chemotherapy, topical steroids, or immune-suppressants in the last 30 days.

What prior data suggests that InnovaMatrix AC porcine placental ECM therapy is safe for treating diabetic foot ulcers?

Research has shown that InnovaMatrix AC, a treatment made from pig placental tissue, is generally safe for patients. Studies have found it rarely causes serious side effects. In everyday use, patients with hard-to-heal wounds, such as diabetic foot ulcers, reported few problems. While minor side effects might occur, they are usually not serious. This suggests the treatment is safe for managing diabetic foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic foot ulcers, which typically involve wound care and offloading techniques, InnovaMatrix AC uses porcine placental extracellular matrix (ECM) as a key component. Researchers are excited because the porcine placental ECM provides a unique scaffold that can promote tissue regeneration and healing. This innovative approach leverages natural biological materials to potentially enhance the healing process more effectively than traditional methods.

What evidence suggests that InnovaMatrix AC porcine placental ECM therapy might be an effective treatment for diabetic foot ulcers?

Research has shown that InnovaMatrix AC, a treatment derived from pig placenta tissue, may aid in healing stubborn diabetic foot ulcers (DFUs). Studies comparing this treatment to others have found it effective in managing these persistent wounds. Specifically, patients using InnovaMatrix AC experienced better healing rates than with some other treatments. This therapy supports the body's natural healing by creating a conducive environment. While more data is being collected, early results appear promising for those with non-healing DFUs. ^{1 3 4 6 7}

Who Is on the Research Team?

Thomas E Serena, MD

Principal Investigator

SerenaGroup, Inc.

Are You a Good Fit for This Trial?

This trial is for people with Type 1 or Type 2 diabetes who have a chronic diabetic foot ulcer classified as Wagner 1 or 2, sized between 0.75cm² and less than 5.0 cm², present for at least 30 days, and with good blood flow to the affected area. Participants must be medically stable, willing to use a porcine product, not pregnant or breastfeeding, without recent surgeries or certain treatments on the ulcer.

Inclusion Criteria

Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment

Patients who are willing and able to attend all follow up visits

Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12%

Exclusion Criteria

In the last 10 days - Chemical debridement, hypochlorous acid or Dakin's solution, medical honey therapy

You have a skin cancer near the diabetic ulcer being studied.

You have received hyperbaric oxygen therapy in the past week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible subjects receive weekly applications of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• InnovaMatrix AC porcine placental ECM therapy

Trial Overview The study is observing how safe and effective InnovaMatrix AC porcine placental ECM therapy is when applied weekly to chronic diabetic foot ulcers (DFUs), alongside standard wound care practices.

How Is the Trial Designed?

Group I: InnovaMatrix AC porcine placental ECM therapy Experimental Treatment 1 Intervention

Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Who Is Running the Clinical Trial?

ConvaTec Inc.

Lead Sponsor

Trials

52

Recruited

5,900+

SerenaGroup, Inc.

Lead Sponsor

Trials

32

Recruited

3,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403330/

Comparative effectiveness of porcine placental ... This study examines the comparative effectiveness of porcine placental extracellular matrix against other well-established cellular, acellular ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07170566

A Retrospective, Observational Study of the Real-world ... One such CAMP and the focus of this study is InnovaMatrix® AC, a decellularised ECM topical wound covering derived from porcine placental tissue ...

3. 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) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05687656

Sterilised, Porcine Placental Tissue in the Treatment of ... To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40709457/

Comparative effectiveness of porcine placental ... Comparative effectiveness of porcine placental extracellular matrix against other cellular, acellular and matrix-like products in diabetic foot ...

6. 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 ...

7. clinicaltrial.be clinicaltrial.be/en/details/188907?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Sterilised, Porcine Placental Tissue in the Treatment of... All subjects will be used for the analysis of efficacy and safety data. Interventions 1. InnovaMatrix AC porcine placental ECM therapy. Device.