Diabetic Foot Ulcer (DFU), Lower Extremity
Conditions
Keywords
diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane, foot diseases, foot ulcer, conventional wound management
Brief summary
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.
Interventions
OTHERGraft 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.
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.
Sponsors
LifeNet Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 12 Weeks | Proportion of diabetic foot ulcers 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 |
| Change in Wound Area | 12 weeks | Change in wound area over time |
| Assessment of Wound Closure Rates in Study Participants | 12 weeks | Number of subjects with a healed wound |
| Infection | 12 weeks | Rate of wound infection |
| Reoccurrence | 14 weeks | Rate of re-occurrence of wound during follow-up period |
| 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 |
Countries
United States
Outcome results
None listed