InnovaMatrix for Ulcers

(IDEAL Trial)

Recruiting at 8 trial locations

Overseen By Andrew Thomas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ConvaTec Inc.

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

Disqualifiers: Pregnancy, Osteomyelitis, End stage renal, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called InnovaMatrix® AC, a wound care product, to determine if it heals stubborn diabetic foot ulcers more effectively than usual care. Diabetic foot ulcers are open wounds that are difficult to heal and often appear on the feet of people with diabetes. The trial compares two groups: one receiving only standard care and the other receiving both standard care and the new treatment. Suitable participants have diabetes and a foot ulcer that hasn't significantly healed in at least four weeks. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options for diabetic foot ulcers.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are taking immunosuppressants, high-dose corticosteroids, or medications that might interfere with wound healing, you may not be eligible to participate.

What prior data suggests that InnovaMatrix® AC is safe for managing diabetic foot ulcers?

Research has shown that InnovaMatrix AC is generally safe for people. In a real-world study, participants reported no negative side effects, indicating that the treatment is usually well-tolerated. Additionally, the FDA has approved InnovaMatrix AC for treating wounds, such as diabetic foot ulcers. Its approval for other types of wounds further confirms its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

InnovaMatrix® AC is unique because it incorporates a specialized material known as PPECM (Porcine Placental Extracellular Matrix) to promote healing in ulcers. Unlike the standard care, which typically involves cleansing, debridement, and maintaining a moist wound environment, InnovaMatrix® AC offers a bioactive scaffold that encourages tissue regeneration and healing. Researchers are excited about this treatment because it could potentially speed up the healing process and improve outcomes by actively supporting the body's natural healing mechanisms, offering a novel approach to managing ulcers.

What evidence suggests that InnovaMatrix® AC might be an effective treatment for diabetic foot ulcers?

Research has shown that InnovaMatrix® AC, which uses a special material from pig placenta, may aid in healing difficult wounds. In studies, 53% of wounds treated with this material healed, even when many were serious. Participants in the "Standard of Care + Intervention" arm of this trial will receive InnovaMatrix® AC. Results from previous studies also showed that wounds could shrink by more than 50% in just four weeks before using InnovaMatrix® AC. This suggests it can be quite effective for hard-to-heal diabetic foot ulcers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with hard-to-heal diabetic foot ulcers. Participants should be adults who can follow the study procedures and visit schedule. People are excluded if they have other significant health issues that could affect wound healing or if they're participating in another clinical study.

Inclusion Criteria

I am at least 21 years old.

Subjects must be willing to participate in all study procedures and follow-up evaluations

BMI must be ≤45

Exclusion Criteria

Subjects with a life expectancy of less than 6 months are excluded

My ulcers do not meet the specific exclusion criteria.

My target ulcers do not show signs of infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Consecutive weekly application of PPECM for the 12-week study period, with no more than 12 applications

12 weeks

Weekly visits for PPECM application

Follow-up

Participants are monitored for safety and effectiveness after treatment, including confirmation of wound closure

2 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• InnovaMatrix® AC

Trial Overview The trial is testing InnovaMatrix® AC, a new treatment for diabetic foot ulcers, against standard care alone. It's designed to see if adding InnovaMatrix® AC improves wound healing. Patients will be randomly assigned to either receive this new treatment along with standard care or just the standard care.

How Is the Trial Designed?

Group I: Standard of Care + Intervention Experimental Treatment 1 Intervention

SOC arm with the following modifications: * Consecutive weekly application of PPECM for the 12-week study period. * Subjects will receive no more than 12 applications of PPECM Note: PPECM should be applied after standard wound cleansing and debridement procedures, prior to the application of primary wound dressing, in accordance with the IFU.

Group II: Standard of Care (SOC) Active Control 1 Intervention

Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited; Wound bed debridement, if clinically indicated. Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate; A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin; Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and, Appropriate use of systemic antibiotics.

Who Is Running the Clinical Trial?

ConvaTec Inc.

Lead Sponsor

Trials

52

Recruited

5,900+

Published Research Related to This Trial

The study found that using a new acellular synthetic matrix (ASM) in addition to standard care (SC) significantly reduced the mean healing time for chronic venous leg ulcers (VLUs) to 73.1 days compared to 83.5 days for those treated with SC alone, based on a comparison of 53 patients in the ASM group and matched data from a larger cohort.

The results suggest that the ASM could be a promising adjunct treatment for non-healing venous ulcers, although the findings are sensitive to unobserved factors that could influence healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control. Shannon, R., Nelson, A.[2021]

A review of 16 high-evidence studies identified 17 products and technologies that effectively promote healing in pressure ulcers, categorized into various therapeutic approaches.

These products not only enhance healing and reduce lesion size but also aid in debridement and minimize contamination, demonstrating their comprehensive role in pressure ulcer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Products and technologies for treating patients with evidence-based pressure ulcers. Figueira, TN., Backes, MTS., Knihs, NDS., et al.[2022]

In a study of 60 patients with diabetic foot ulcers, the Integra Flowable Wound Matrix led to a significantly higher complete healing rate of 86.95% compared to 52.17% for the wet dressing, demonstrating its efficacy in treating these complex wounds.

The use of the Integra Flowable Wound Matrix was associated with lower rates of amputation and rehospitalization compared to the control group, highlighting its safety and effectiveness in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial. Campitiello, F., Mancone, M., Della Corte, A., et al.[2022]

Diabetic foot ulcers are common chronic wounds in diabetes patients that often do not heal despite standard treatments, leading to significant health issues.

Compounded formulations that combine multiple drugs with different mechanisms of action may provide a personalized and effective alternative for healing these ulcers, allowing adjustments based on individual patient needs and progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compounding Pearls -- Wound Care: Diabetic Foot Ulcers, Part 1. Riepl, M.[2020]

Acellular dermal matrices (ADMs) like Integra® and PELNAC® show superior ability to support the growth of blood vessels and skin cells, making them effective for treating hard-to-heal skin ulcers and defects.

In animal studies, pre-seeding Integra® with human dermal microvascular endothelial cells significantly improved the integration and vascularization of the matrix, suggesting a promising approach for enhancing wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Capability of Clinically Employed Dermal Regeneration Scaffolds to Support Vascularization for Tissue Bioengineering. Agostinis, C., Spazzapan, M., Vuerich, R., et al.[2021]

In a study involving 130 adults with Stage III or IV pressure ulcers, the Oasis® Wound Matrix (SIS) treatment led to a 55% rate of 90% reduction in ulcer size, compared to 38% with standard care, indicating its effectiveness in promoting wound healing.

While the complete healing rate was 40% for the SIS group versus 29% for standard care, the difference was not statistically significant, suggesting that while SIS may enhance healing, it may not guarantee complete healing compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. Brown-Etris, M., Milne, CT., Hodde, JP.[2019]

In a study of 299 participants with clinically infected diabetic foot ulcers, only 45.5% achieved healing within 12 months, highlighting the generally poor clinical outcomes for these patients.

Factors negatively impacting healing included longer ulcer duration (≥2 months) and higher PEDIS perfusion grades (≥2), while having a single ulcer was associated with better healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. Ndosi, M., Wright-Hughes, A., Brown, S., et al.[2022]

Citations

1. 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 ...

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

A Retrospective, Observational Study of the Real-world ... Wound area showed ≥50% reduction in 4-weeks preceding initial InnovaMatrix® AC application. Cases where InnovaMatrix® AC was not applied at a ...

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 Results showed 53% healing in this population of which 44% of wounds were classified as 'life or limb threatening'9. References. 1. Sun, H., et al., IDF ...

4. 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 ...

5. 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).

6. convatec.com convatec.com/advanced-wound-care/extracellular-matrix/innovamatrix-ac/

InnovaMatrix AC InnovaMatrix AC is the first FDA-cleared placental-derived extracellular matrix medical device for wound management.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193552.pdf

K193552.pdf - accessdata.fda.gov InnovaMatrix™ is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ...

8. convatecgroup.com convatecgroup.com/media-articles/press-releases/2024/convatec_update_on_innovamatrix_ac_clinical_data/

Convatec update on InnovaMatrix® AC clinical data The InnovaMatrix® products are cleared for use by the FDA for the management of wounds including pressure ulcers, diabetic foot ulcers, venous ...