MicroMatrix® Flex for Wounds and Injuries

Recruiting at 2 trial locations

Overseen By Saarah Mohammedi Alseginy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integra LifeSciences Corporation

Disqualifiers: Burns, Unmanaged infection, Porcine allergy, 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: Unknown

Duration: 12 weeks

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if your medication might interfere with the study, the investigator may advise changes.

What data supports the effectiveness of the treatment MicroMatrix® Flex for wounds and injuries?

Research shows that porcine urinary bladder matrix (UBM), a component of MicroMatrix® Flex, can help diabetic wounds heal by reducing inflammation to levels similar to those in non-diabetic patients, suggesting it may be effective in promoting wound healing. ^{1 2 3 4 5}

Is MicroMatrix® Flex safe for use in humans?

Research on porcine urinary bladder matrix (UBM), which is similar to MicroMatrix® Flex, suggests it is generally safe for treating wounds, including diabetic foot ulcers. Studies show it helps in wound healing by reducing inflammation, and no major safety concerns have been reported. ^{1 2 6 7 8}

How is the treatment MicroMatrix® Flex unique for wound healing?

MicroMatrix® Flex, derived from porcine urinary bladder matrix, is unique because it promotes tissue regeneration by modulating inflammation and enhancing the healing environment, which is particularly beneficial for complicated wounds where traditional reconstructive options may not be suitable. ^{1 2 6 8 9}

What is the purpose of this trial?

To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.

Research Team

Claire Witherel, Ph.D.

Principal Investigator

Integra LifeSciences Corporation

Eligibility Criteria

This trial is for adults over 22 with various types of wounds, including pressure injuries, venous ulcers, and wounds from infections or surgeries. Participants must be able to follow the study plan and have signed consent forms. People can't join if they have unmanaged infections, allergies to pig materials, are in another conflicting clinical trial, or have burns causing their wound.

Inclusion Criteria

I have a diagnosed wound or ulcer.

I am 22 years old or older.

I am willing and able to follow the study's requirements and attend all follow-up appointments.

Exclusion Criteria

Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements

I do not have any untreated infections or bone infections.

Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer to treat tunneling and/or undermining wounds

12 weeks

Regular visits for wound assessment and treatment

Follow-up

Participants are monitored for wound closure and post-operative complications

4 weeks

Follow-up visits for skin graft assessment

Treatment Details

Interventions

• MicroMatrix® Flex

Trial Overview The safety and effectiveness of MicroMatrix® Flex are being tested on patients with tunneling wounds. The product aims to help heal complex wounds by providing a scaffold for new tissue growth.

Participant Groups

Group I: Subjects with tunneling and/or undermining wounds Experimental Treatment 3 Interventions

MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.

MicroMatrix® Flex is already approved in United States for the following indications:

Approved in United States as MicroMatrix Flex for:

• partial and full-thickness wounds
• pressure ulcers
• venous ulcers
• diabetic ulcers
• chronic vascular ulcers
• tunneled/undermined wounds
• surgical wounds
• trauma wounds
• draining wounds

Who Is Running the Clinical Trial?

Integra LifeSciences Corporation

Lead Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

In a multicenter study involving 95 subjects, MatriStem MicroMatrix and MatriStem Wound Matrix demonstrated similar healing outcomes for non-healing diabetic foot ulcers compared to Dermagraft, with no significant differences in wound healing rates or complete closure between the two treatments.

Patients treated with MatriStem showed significant improvements in quality of life and lower treatment costs, suggesting that while the healing efficacy is comparable, MatriStem may offer economic and patient-centered advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. Frykberg, RG., Cazzell, SM., Arroyo-Rivera, J., et al.[2018]

In diabetic patients, wounds showed higher levels of pro-inflammatory M1 macrophages compared to nondiabetic patients before treatment, indicating a more intense inflammatory response.

After treatment with porcine urinary bladder matrix (UBM), diabetic patients experienced a significant reduction in pro-inflammatory markers, leading to an inflammatory state similar to that of nondiabetic patients, suggesting UBM may enhance wound healing in diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of inflammation in wounds of diabetic patients treated with porcine urinary bladder matrix. Paige, JT., Kremer, M., Landry, J., et al.[2023]

In a study of 50 patients with diabetic foot ulcers (DFUs) who were not candidates for vascular interventions, a two-staged surgical approach using polymethylmethacrylate (PMMA) implantation and induced membrane (IM) formation resulted in a significantly higher healing rate (57.1% vs. 22.7%) and shorter healing duration (13.1 weeks vs. 26.4 weeks) compared to conventional wound debridement.

At a follow-up of approximately 16.8 months, the survival rate was notably higher in the PMMA group (92.9%) compared to the conventional group (68.2%), indicating that this surgical approach may enhance patient outcomes in those with DFUs and nonrevascularized peripheral arterial disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Induced Membrane Formation Followed by Polymethylmethacrylate Implantation on Diabetic Foot Ulcer Healing When Revascularization Is Not Feasible. Liu, C., You, JX., Chen, YX., et al.[2022]

Diabetic foot ulcers (DFUs) are a serious complication for diabetic patients, often leading to chronic, non-healing wounds due to unresolved inflammation, which prevents proper healing.

Modulating the inflammatory response in the DFU microenvironment is a promising therapeutic strategy, with a focus on biomaterials-based delivery systems that can enhance tissue regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thou shall not heal: Overcoming the non-healing behaviour of diabetic foot ulcers by engineering the inflammatory microenvironment. Monaghan, MG., Borah, R., Thomsen, C., et al.[2023]

The E-Matrix, a novel injectable scaffolding matrix derived from porcine collagen, shows promise in accelerating wound healing for diabetic foot ulcers, mimicking fetal tissue repair mechanisms.

In a pilot study involving six patients, the E-Matrix led to an impressive average wound size reduction of 72% within just 2 weeks after injection, indicating its potential efficacy in treating chronic nonhealing wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans. Marston, WA., Usala, A., Hill, RS., et al.[2016]

Urinary bladder matrix (UBM) was successfully used to treat complicated open wounds in 5 patients who did not respond to conventional therapies, with epithelialization occurring in as little as 3 weeks to as long as 28 weeks depending on the severity of the injury.

The application of UBM, often in combination with vacuum-assisted closure therapy, demonstrated effective tissue remodeling and healing in various challenging cases, suggesting its potential as a viable treatment option for difficult wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of urinary bladder matrix in the treatment of complicated open wounds. Lanteri Parcells, A., Abernathie, B., Datiashvili, R.[2015]

In a study of 61 participants with large diabetic foot ulcers (DFUs), the acellular dermal matrix allograft DermACELL (D-ADM) achieved 100% granulation in 47 participants within an average of 4 weeks, demonstrating its efficacy in promoting wound healing.

The treatment resulted in an average wound area reduction of 80.3% over 16 weeks, with no complications reported, indicating that D-ADM is a safe option for managing complex DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Cazzell, S., Moyer, PM., Samsell, B., et al.[2020]

In a study of 34 patients with chronic ulcers, the use of porcine urinary bladder matrix (UBM) led to full healing in all cases, with an average healing time of 9.8 weeks after application.

The study highlights that UBM is effective for treating diabetic and venous ulcers when combined with proper management of risk factors and appropriate dressing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porcine urinary bladder matrix: a retrospective study and establishment of protocol. Lecheminant, J., Field, C.[2012]

Porcine urinary bladder matrix (UBM) significantly enhances the motility of bone marrow-derived macrophages and promotes their polarization towards the M2 type, which is associated with tissue regeneration and healing.

In a study involving 12 mice, UBM showed superior effects in promoting macrophage activity and inflammatory response compared to absorbable dressings, indicating its potential as a more effective stent material for wound repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of porcine urinary bladder matrix on motility and polarization of bone marrow-derived macrophages in mice]. Tang, XY., Liu, CY., Chu, GP., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. [2018]

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

Modulation of inflammation in wounds of diabetic patients treated with porcine urinary bladder matrix. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of Induced Membrane Formation Followed by Polymethylmethacrylate Implantation on Diabetic Foot Ulcer Healing When Revascularization Is Not Feasible. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Thou shall not heal: Overcoming the non-healing behaviour of diabetic foot ulcers by engineering the inflammatory microenvironment. [2023]

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

Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans. [2016]

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

The use of urinary bladder matrix in the treatment of complicated open wounds. [2015]

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

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Porcine urinary bladder matrix: a retrospective study and establishment of protocol. [2012]

9. China pubmed.ncbi.nlm.nih.gov

[Effects of porcine urinary bladder matrix on motility and polarization of bone marrow-derived macrophages in mice]. [2023]