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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
For subjects with a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post termination visit
Awards & highlights

Study Summary

This trial will test whether Matrion can help heal diabetic foot ulcers. Matrion is made from placental tissue and is safe for surgical use.

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.Check my eligibility
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.See study design
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 diabetes and have been on a stable treatment for at least 30 days.
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I can follow instructions for wound care and dressing changes.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Wound Healing
Secondary outcome measures
Grafts Used
Incidence of Treatment Emergent Adverse Events
Infection
+3 more

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.

Find a Location

Who is running the clinical trial?

LifeNet HealthLead Sponsor
14 Previous Clinical Trials
1,172 Total Patients Enrolled
3 Trials studying Diabetic Foot
297 Patients Enrolled for Diabetic Foot

Media Library

Matrion™ (Decellularized Placental Membrane) Clinical Trial Eligibility Overview. Trial Name: NCT05087758 — N/A
Diabetic Foot Research Study Groups: Matrion decellularized placental membrane, Conventional Care Wound Management
Diabetic Foot Clinical Trial 2023: Matrion™ Highlights & Side Effects. Trial Name: NCT05087758 — N/A
Matrion™ (Decellularized Placental Membrane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087758 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest number of participants allowed in this clinical trial?

"In order to conduct this trial, the sponsor, LifeNet Health needs 120 eligible participants. Several sites are hosting this research project including Albuquerque Associated Podiatrists in New mexico and Compass Medical Research Center LLC in Arizona."

Answered by AI

Are candidates aged under 75 years old eligible for admission into this experiment?

"Eligibility for this clinical trial is limited to individuals between 21 and 80 years of age."

Answered by AI

Is this research endeavor taking on additional participants?

"A quick glance at clinicaltrials.gov reveals that this medical trial is seeking participants, having first been posted on March 1st of 2022 and most recently amended on April 14th."

Answered by AI

To what group of individuals is enrollment in this medical experiment open?

"This clinical trial is currently enrolling 120 individuals aged 21 to 80 with diabetic foot. Qualified participants must meet the following criteria: adhere to Infectious disease Society of America standards for infection-free, identify as male or female, have a diagnosis of Type I or II diabetes according to American Diabetes Association guidelines and be on steady anti-diabetic drugs for at least one month before baseline visit; possess a single target ulcer larger than 1 cm2 but not exceeding 25cm2 in said wound depth being no more than 9mm; grade 1 superficial diabetic ulcers including full skin tissue without underlying harm; transcutaneous oxygen measurement of 30"

Answered by AI

Are there multiple sites conducting this experiment throughout the state?

"Presently, the study is seeking participants from a total of 6 different sites. The available locations are Albuquerque, Tucson and San Diego as well 3 other cities. It's important to pick the closest option in order to reduce unnecessary travel needs when taking part."

Answered by AI
~39 spots leftby Apr 2025