Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers (NCT05087758) | Clinical Trial Compass
CompletedNot Applicable
Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
United States108 participantsStarted 2022-03-01
Plain-language summary
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be male or female, between 21 and 80 years of age at the time of consent
. 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
. Have a full-thickness wound of the lower extremity
. Have a single target ulcer
. Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:
. Have an absence of infection based on Infectious Disease Society of America criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.