Matrion for Foot Ulcer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LifeNet Health

Must be taking: Anti-diabetics

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids

Disqualifiers: Pregnancy, Infection, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Matrion™, a treatment derived from human birth tissue, in healing diabetic foot ulcers compared to standard wound care. The study aims to determine if Matrion™ can promote better and faster wound healing. Individuals with a diabetic foot ulcer present for at least 30 days and impacting daily activities may qualify. Participants will receive either the Matrion™ treatment or standard wound care for comparison. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

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

The trial does not specify if you need to stop taking your current medications. However, you must have been on a stable anti-diabetic treatment for at least 30 days before joining the study.

What prior data suggests that Matrion is safe for treating diabetic foot ulcers?

Research shows that placenta-derived treatments, such as Matrion™, are generally safe for treating chronic wounds. Studies have found that these treatments heal ulcers more effectively than standard methods. While direct safety data for Matrion is limited, placenta-based products are typically well-tolerated. They undergo careful processing to remove cells and ensure cleanliness, reducing the risk of side effects. Although some risks may exist, current evidence suggests that Matrion is a promising and safe option for managing foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach of using dressings and topical agents for foot ulcers, Matrion is unique because it uses a decellularized placental membrane. This means it harnesses the natural healing properties found in placental tissue, potentially providing a biological scaffold that supports and accelerates tissue regeneration. Researchers are excited about Matrion because it may offer a more effective way to heal foot ulcers by promoting faster and more complete healing compared to conventional wound management techniques.

What evidence suggests that Matrion could be an effective treatment for diabetic foot ulcers?

Research has shown that materials made from the placenta, such as Matrion, can heal diabetic foot ulcers more effectively than standard treatments. In this trial, participants will receive either Matrion or conventional wound management. Studies suggest these materials help wounds heal completely more often than usual care methods. Matrion, made from human birth tissue, undergoes treatment to ensure safety and cleanliness and is used in surgeries. Early findings indicate that these placental membranes might improve healing for patients with difficult-to-heal wounds. This treatment could reduce the impact of chronic ulcers by promoting faster and more complete healing. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic foot ulcers. Participants should have a wound that hasn't healed in at least four weeks despite standard care and must be able to attend regular follow-up visits. People with severe infection, gangrene, or who are receiving certain other treatments for their ulcer are not eligible.

Inclusion Criteria

I am between 21 and 80 years old.

I can follow instructions for wound care and pressure relief.

Ability to understand the study requirements, provide written informed consent, and agree to study restrictions

Exclusion Criteria

Pregnant or lactating

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

My wound is less than 30 days old and has shrunk by at least 50% recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Matrion decellularized placental membrane or conventional wound management for diabetic foot ulcers

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the rate of re-occurrence of wounds

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Matrion Decellularized Placental Membrane

Trial Overview The study tests Matrion, a new placental membrane product, against conventional wound care methods in treating diabetic foot ulcers. Matrion includes multiple layers of the human birth tissue and is processed to be acellular and sterile for surgical use.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Conventional Wound Management

Group II: Arm 1: Experimental Treatment 1 Intervention

Matrion

Who Is Running the Clinical Trial?

LifeNet Health

Lead Sponsor

Trials

15

Recruited

1,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116876?lastUpdPost=2020-03-16_

Study Details | Matrion Decellularized Placental Membrane ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11183911/

Assessing placental membrane treatment efficiency in ... The findings suggest that while L‐AC might be slightly more effective in complete ulcer healing, RE‐AC offers overall better treatment efficiency.

3. trialx.com trialx.com/clinical-trials/listings/280959/matriontm-decellularized-placental-membrane-in-subjects-with-diabetic-foot-ulcers/

Matrion™ Decellularized Placental Membrane in Subjects ... Clinical trial for Diabetic Foot | Lower Extremity Wound , Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers.

4. magonlinelibrary.com magonlinelibrary.com/doi/10.12968/jowc.2025.0428

Efficacy of a full-thickness decellularised placental ... This approach has the potential to significantly improve patient outcomes and reduce the societal burden of hard-to-heal wounds. Annually, >18 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1871402124002315

Placenta-derived biomaterials vs. standard care in chronic ... Placenta-derived biomaterials therapies have been shown to be more effective for achieving complete ulcer healing compared to current conventional treatments ...