Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

Sponsor

LifeNet Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05087758

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Lower Extremity Wound	Other: Matrion Other: Conventional Care Wound Management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of Matrion on the wound healing rate of diabetic foot ulcers.The study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of Matrion on the wound healing rate of diabetic foot ulcers.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Trial to Assess the Clinical Effectiveness of Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Matrion decellularized placental membrane Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer.	Other: Matrion Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
Active Comparator: Conventional Care Wound Management Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis.	Other: Conventional Care Wound Management Advanced wound care with debridement and dressings

Arm

Intervention/Treatment

Experimental: Matrion decellularized placental membrane

Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer.

Other: Matrion

Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers

Active Comparator: Conventional Care Wound Management

Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis.

Other: Conventional Care Wound Management

Advanced wound care with debridement and dressings

Outcome Measures

Primary Outcome Measures

Wound Healing [12 weeks]
Proportion of chronic DFUs that have achieved complete wound closure

Secondary Outcome Measures

Speed of Wound Closure [12 weeks]
Time to wound closure measured from the baseline visit to the termination visit
Wound Area [12 weeks]
Change in wound area over time
Infection [12 weeks]
Rate of wound infection
Reoccurrence [6 months post termination visit]
Rate of reoccurrence of wound post treatment
Grafts Used [12 weeks]
Average number of Matrion grafts used per subject
Incidence of Treatment Emergent Adverse Events [12 weeks]
Collection of adverse events, including changes in vital signs, ABI, and physical exams

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To be considered eligible to participate in the study, a subject must meet the inclusion criteria listed below:

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:

Grade 1: superficial diabetic ulcer including the full skin thickness but not underlying tissue
Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess of osteomyelitis

Have an absence of infection based on Infectious Disease Society of America criteria
Have an adequate circulation to the affected lower extremity, defined as at least one these criteria:

Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mmHg
Ankle-brachial index (ABI) greater than 0.75
At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries

Have the ability to comply with off-loading (if required for specific wound) and dressing change requirements
Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
Have provided written authorization for use and disclosure of protected health information
Have a life expectancy of greater than 6 months

Exclusion Criteria:

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:

Be pregnant or lactating
Have a wound that decreased in size ≥50% between the Screening and Baseline Visits
Have circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit
Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
Have a sensitivity to any of the following antibiotics: Lincomycin, Polymyxin B Sulfate, and/or Vancomycin
Have a sensitivity to N-Lauroyl Sarcosinate, and/or Benzonase® or Denarase®
Have the wound treated with biomedical or topical growth factors within the previous 30 days before the screening visit
Need for any additional concomitant dressing material other than the ones approved for this study
Have clinical signs of an infection at the study ulcer site
Have the inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast)
Have a known or suspected disease of the immune system
Have an active or untreated malignancy or active, uncontrolled connective tissue disease
Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit
Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit
Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening
Have evidence of active Charcot disease
Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Compass Medical Research Center, LLC	Tucson	Arizona	United States	85715
2	Limb Preservation Platform, INC	Fresno	California	United States	93710
3	ILD Research Center	San Diego	California	United States	92130
4	Center for Clinical Research, INC	San Francisco	California	United States	94115
5	Albuquerque Associated Podiatrists	Albuquerque	New Mexico	United States	87111
6	Purvis-Moyer Foot and Ankle Center	Rocky Mount	North Carolina	United States	27804