What side effects are associated with this type of intervention?

Common treatments for diabetic foot ulcers that provide a scaffold for tissue regeneration and deliver bioactive molecules, such as placental membrane products and skin substitutes, generally have a favorable safety profile. However, potential side effects can include local infection, allergic reactions, and inflammation at the application site. Additionally, there may be a risk of delayed wound healing or graft rejection. It is important for patients to be monitored closely by their healthcare provider to manage any adverse effects promptly.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers that focus on tissue regeneration and healing. One notable example is the use of bioengineered skin substitutes like Apligraf and Dermagraft. These products provide a scaffold for tissue regeneration and deliver bioactive molecules to promote healing, similar to the approach used by Matrion™. Apligraf is composed of living cells and structural proteins, while Dermagraft consists of fibroblasts on a bioabsorbable scaffold. Both have been shown to be effective in promoting the healing of diabetic foot ulcers.

What other types of research exist?

Promising alternatives to Matrion™ for diabetic foot patients include: <ol> <li>Human Acellular Dermal Matrix (HADM): Used for hernia repair and complex abdominal wall defects, HADM provides a scaffold for tissue regeneration.</li> <li></li> </ol> Poly-4-hydroxybutyrate (P4HB) Mesh: This fully absorbable material has shown promising results in hernia repair and could be adapted for wound healing. 3. Autologous Platelet Concentrates (APC): APC, also known as platelet-rich plasma, has been used as an adjunct to oral surgery and shows potential in promoting wound healing. 4. Low-Level Laser Therapy (LLLT): Although primarily used in combination with other therapies, LLLT has shown potential in improving healing and symptoms related to chronic wounds.

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Decellularized Placental Membrane

Matrion for Diabetic Foot Ulcers

N/A

Recruiting

Research Sponsored by LifeNet Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a single target ulcer

Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2

Must not have

Need for any additional concomitant dressing material other than the ones approved for this study

Have an active or untreated malignancy or active, uncontrolled connective tissue disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post termination visit

Awards & highlights

No Placebo-Only Group

Summary

This trial uses Matrion™, a sterilized placental tissue product, to treat people with diabetic foot ulcers. The product helps protect and heal wounds by providing a sterile, protective layer.

Who is the study for?

Adults aged 21-80 with Type I or II diabetes and a diabetic foot ulcer present for at least 30 days can join this trial. They must have stable anti-diabetic treatment for the past month, good understanding of study requirements, life expectancy over 6 months, and adequate circulation to the affected limb. Pregnant individuals, those with severe kidney issues or immune diseases, recent recipients of certain treatments like immunosuppressants or skin equivalents are excluded.

What is being tested?

The trial is testing Matrion™, a new placental membrane treatment against conventional care for healing diabetic foot ulcers. Participants will be randomly assigned to receive either Matrion™—a sterile product made from human birth tissue—or standard wound management practices.

What are the potential side effects?

Potential side effects may include reactions to components in Matrion™ such as N-Lauroyl Sarcosinate and Benzonase®, local infection risks due to wound dressing changes, and possible allergic responses if sensitive to antibiotics used during processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have one target ulcer.

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I have a diabetic foot ulcer for over 30 days, graded 1 or 2.

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I have a deep wound on my leg.

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My blood flow to my leg is good.

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I am between 21 and 80 years old.

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My wound is between 1 cm2 and 25 cm2 in area and no deeper than 9 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't need extra dressing materials beyond what this study provides.

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I have an untreated cancer or an active connective tissue disease.

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I have poor blood circulation in my legs.

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My wound shows signs of infection.

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I cannot use devices like a surgical shoe or cast to relieve pressure on my foot.

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I had a procedure to improve blood flow in my limb less than 4 weeks ago.

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I have non-healing wounds with dead tissue or pus that can't be cleaned away.

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I have a condition affecting my immune system.

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My wound has shrunk by half or more since my last doctor's visit.

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I have active Charcot disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post termination visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post termination visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post termination visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Wound Healing

Secondary study objectives

Grafts Used

Incidence of Treatment Emergent Adverse Events

Infection

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Matrion decellularized placental membraneExperimental Treatment1 Intervention

Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer.

Group II: Conventional Care Wound ManagementActive Control1 Intervention

Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetic foot ulcers include biologic therapies such as amniotic fluid-derived multipotent stromal cells (AFMSCs) and decellularized placental membranes like Matrion™. These treatments work by providing a scaffold for tissue regeneration and delivering bioactive molecules that promote healing. AFMSCs modulate inflammatory cell behavior, particularly macrophages, to enhance wound healing through their paracrine activities. Matrion™ offers a sterile, acellular structure that supports tissue growth and repair. These mechanisms are crucial for diabetic foot patients as they address the impaired healing process, reduce the risk of infection, and potentially prevent amputations.

Amniotic fluid-derived multipotent stromal cells drive diabetic wound healing through modulation of macrophages.The contralateral extremity has also benefit from the locally administered bone marrow-derived mononuclear cells and cord blood serum in diabetic ischemic wound healing.