Diabetic Foot, Lower Extremity Wound
Conditions
Keywords
diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane
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.
Interventions
OTHERMatrion
Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
OTHERConventional Care Wound Management
Advanced wound care with debridement and dressings
Sponsors
LifeNet Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To be considered eligible to participate in the study, a subject must meet the inclusion criteria listed below: 1. Be male or female, between 21 and 80 years of age at the time of consent 2. 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 3. Have a full-thickness wound of the lower extremity 4. Have a single target ulcer 5. 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 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 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 7. Have an absence of infection based on Infectious Disease Society of America criteria 8. 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 9. Have the ability to comply with off-loading (if required for specific wound) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 12 weeks | Proportion of chronic DFUs that have achieved complete wound closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Grafts Used | 12 weeks | Average number of Matrion grafts used per subject |
| Reoccurrence | 6 months post termination visit | Rate of reoccurrence of wound post treatment |
| Incidence of Treatment Emergent Adverse Events | 12 weeks | Collection of adverse events, including changes in vital signs, ABI, and physical exams |
| Infection | 12 weeks | Rate of wound infection |
Countries
United States
Outcome results
None listed