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Matrion for Diabetic Foot Ulcers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I don't need extra dressing materials beyond what this study provides.Your blood test showed high levels of creatinine within the last month.I have one target ulcer.Your liver enzymes are more than three times the normal level.I have an untreated cancer or an active connective tissue disease.I have poor blood circulation in my legs.You are allergic to lincomycin, polymyxin B sulfate, or vancomycin.I haven't used any growth factors on my wound in the last 30 days.My wound shows signs of infection.I haven't had treatments like chemotherapy, radiotherapy, or steroids in the last 30 days.I cannot use devices like a surgical shoe or cast to relieve pressure on my foot.I had a procedure to improve blood flow in my limb less than 4 weeks ago.I have diabetes and have been on a stable treatment for at least 30 days.I have non-healing wounds with dead tissue or pus that can't be cleaned away.I can follow instructions for wound care and dressing changes.I have had a skin graft treatment in the last 4 weeks.I have a diabetic foot ulcer for over 30 days, graded 1 or 2.You do not have an infection according to the guidelines of the Infectious Disease Society of America.I have a deep wound on my leg.I have a condition affecting my immune system.You are expected to live for more than 6 months.My wound has shrunk by half or more since my last doctor's visit.I have active Charcot disease.Your blood sugar level, as measured by hemoglobin A1c, is higher than 12% within the last 90 days.My blood flow to my leg is good.You are allergic to N-Lauroyl Sarcosinate, Benzonase®, or Denarase®.I am between 21 and 80 years old.My wound is between 1 cm2 and 25 cm2 in area and no deeper than 9 mm.
- Group 1: Matrion decellularized placental membrane
- Group 2: Conventional Care Wound Management
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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"
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."
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