Purpose

This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

To be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below: 1. Be male or female and aged between 21 and 80 years at the time of informed consent 2. Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit. 3. Have full-thickness wound of the lower extremity, below the ankle 4. Have a single target ulcer 5. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm 6. 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 involving the full skin thickness but not underlying tissues - Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis 7. Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2) 8. Have an adequate circulation to the affected lower extremity, defined as at least one of the criteria within the previous 60 days: - Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mm Hg - Ankle-brachial index (ABI) ranging from 0.8 to 1.2 - At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries 9. Have the ability to comply with off-loading and dressing change requirements 10. 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 11. Have provided written authorization for use and disclosure of protected health information 12. 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: 1. Be pregnant or lactating 2. Subjects with a target wound <30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline/Visit 2) 3. Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening/Visit 1 for subjects with labs collected <30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening) 4. Have a serum creatinine concentration of 3.0 mg/dL or greater within 30 days prior to screening (assessed at Screening/Visit 1 for subjects with labs collected <30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening) 5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin 6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol 7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit 8. Need for any additional concomitant dressing material other than the ones approved for this study 9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2) 10. Have the inability to tolerate an off-loading boot 11. Have a known or suspected disease of the immune system 12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease 13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit 14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline/Visit 2) 15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit 16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening/Visit 1 if subject had labs collected <30 days of screening; assessed at Baseline/Visit 2 if subject had labs collected at screening) 17. Have active Charcot disease 18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening 19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot 20. 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study is a post market, multicenter, randomized, open-label trial designed to evaluate the treatment response of Matrion compared to Conventional Wound Management on the wound healing rate of diabetic foot ulcers. Subjects from each clinical site will be evaluated using protocol-specific eligibility criteria to determine who qualifies for study participation.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Arm 1:
Matrion
  • Other: Graft Application
    Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.
    Other names:
    • Matrion
Other
Arm 2
Conventional Wound Management
  • Other: Wound Dressing Material
    The wound will be debrided and undergo a moist-wound therapy and will be covered with a gauze that is appropriate for the type of wound (moist or dry). Dressings will cover each wound wound for at least 5 days, but no more than 9 days, (7 days +/- 2 days) until the next study visit. Off-loading of the wound is required.

Recruiting Locations

Compass Medical Research Center
Tucson 5318313, Arizona 5551752 85715
Contact:
Heather Kimbriel
520-526-2325
Heather.Kimbriel@gmail.com

Bay Area Foot Care
Castro Valley 5334928, California 5332921 94546
Contact:
Maria Peralta
800-363-1069
maria@ccr-trials.com

Limb Preservaion Platform, Inc.
Fresno 5350937, California 5332921 93710
Contact:
Destiny Blackwell
559-431-1700
destiny@lppresearch.com

Center for Clinical Research, Inc
San Francisco 5391959, California 5332921 94115
Contact:
Maria Peralta
800-363-1069
maria@ccr-trials.com

Bay Area Foot Care
San Francisco 5391959, California 5332921 94117
Contact:
Maria Peralta
800-363-1069
maria@ccr-trials.com

ILD Research Center
Vista 5406602, California 5332921 92081
Contact:
Eric Martinez
760-350-5080
eric@ildresearch.com

Humanity Clinical Research, Corp
Aventura 4146429, Florida 4155751 33180
Contact:
Elena Guerrero
305-607-8454
eguerrero@humanityclinicalresearch.org

South Florida Podiatry
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Kayla R. Wasserman
954-426-4544
kaylarwasserman@gmail.com

Dinamo Research & Diagnostic Center, LLC
Hialeah 4158476, Florida 4155751 33015
Contact:
Andres P Morales
786-536-2425
clinicalcoordinator@dinamoresearch.net

Doctors Research Network, Inc.
Miami 4164138, Florida 4155751 33156
Contact:
Jilliam Ruiz
305-665-3017
jruiz@drnmiami.com

Independent Clinical Research
Decatur 4236895, Illinois 4896861 62521
Contact:
Kehkashan Arshad
217-787-2700
karshad@myfootandanklecenter.com

Independent Clinical Research, LLC
Springfield 4250542, Illinois 4896861 62704
Contact:
Matthew Shirani
217-787-2700
mshirani@myfootandanklecenter.com

US Foot and Ankle Specialists
Raleigh 4487042, North Carolina 4482348 27609
Contact:
Allie Denton
919-213-0261
adenton@us-fas.com

Foot and Ankle Institute of the Carolinas
Rocky Mount 4488762, North Carolina 4482348 27804
Contact:
Ann Keenan, PA-C
215-779-9253
Annkeenan09@gmail.com

Olympus Clinical Research
Katy 4702732, Texas 4736286 77450
Contact:
Albert Blanco
832-805-1197
Alberto.blanco@olympusclinicalresearch.com

Element Research Group
San Antonio 4726206, Texas 4736286 78258
Contact:
Charles Freeman
210-931-0034
cfreeman@elementrg.com

Olympus-Alcanza
Sugar Land 4734825, Texas 4736286 77479
Contact:
Albert Blanco
346-397-4457
alberto.blanco@olympusclinicalresearch.com

Foot and Ankle Specialists of the Mid-Atlantic
Salem 4784112, Virginia 6254928 24175
Contact:
Kristie Cooper (Guilliams)
540-395-3107
kcooper@us-fas.com

More Details

Status
Recruiting
Sponsor
LifeNet Health

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.