Matrion for Diabetic Foot

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Doctors Research Network, Miami, FLDiabetic Foot+1 MoreMatrion - Other
Eligibility
21 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Diabetic Foot
  • Lower Extremity Wound

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 6 months post termination visit

12 weeks
Grafts Used
Incidence of Treatment Emergent Adverse Events
Infection
Speed of Wound Closure
Wound Area
Wound Healing
Month 6
Reoccurrence

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Conventional Care Wound Management
1 of 2
Matrion decellularized placental membrane
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Matrion · No Placebo Group · N/A

Matrion decellularized placental membrane
Other
Experimental Group · 1 Intervention: Matrion · Intervention Types: Other
Conventional Care Wound Management
Other
ActiveComparator Group · 1 Intervention: Conventional Care Wound Management · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post termination visit

Who is running the clinical trial?

LifeNet HealthLead Sponsor
11 Previous Clinical Trials
1,008 Total Patients Enrolled
2 Trials studying Diabetic Foot
263 Patients Enrolled for Diabetic Foot

Eligibility Criteria

Age 21 - 80 · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a wound that is between 1 and 25 square centimeters and less than 9 millimeters deep.
You are expected to live for at least 6 more months.
You have a wound that goes all the way through your skin on your leg or foot.
You have only one ulcer that needs to be treated.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.